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  "name": "FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787    The K170974 clearance document describes the device as follows:    The BD FACSLyric\" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical   configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a   computer workstation. System options include an automated FACS Universal Loader and   a barcode reader.  The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part   of four available manufactured instrument configurations.  BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser  BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser  BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser  BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser  The lower level configurations are upgradeable to higher level configurations by adding   filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm   lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence   channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO).  All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in   height by 24.93 inches in width by 22.8 inches in depth.    The K201814 clearance document describes the device as follows:    Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer.  The modified BD FACSLyric Flow Cytometer consists of the following components.  \" FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations)  \" FACSuite Clinical Software (version 1.4)  \" Modified FACS Universal Loader: updated shaker and modification to the door lock and   sensor connections  \" Modified CMS firmware      BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system   consists of all the above components as FACSLyric Flow Cytometer and additionally contain:  \" BD FACSDuet Sample Preparation system physically and data integrated with the BD   FACSLyric Flow Cytometer  \" FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution.  \" Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor   connections, addition of stabilization bracket",
  "description": "FDA recall Z-0748-2025 — Becton, Dickinson and Company, BD Bio Sciences is recalling FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787    The K170974 clearance document describes the device as follows:    The BD FACSLyric\" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical   configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a   computer workstation. System options include an automated FACS Universal Loader and   a barcode reader.  The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part   of four available manufactured instrument configurations.  BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser  BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser  BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser  BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser  The lower level configurations are upgradeable to higher level configurations by adding   filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm   lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence   channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO).  All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in   height by 24.93 inches in width by 22.8 inches in depth.    The K201814 clearance document describes the device as follows:    Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer.  The modified BD FACSLyric Flow Cytometer consists of the following components.  \" FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations)  \" FACSuite Clinical Software (version 1.4)  \" Modified FACS Universal Loader: updated shaker and modification to the door lock and   sensor connections  \" Modified CMS firmware      BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system   consists of all the above components as FACSLyric Flow Cytometer and additionally contain:  \" BD FACSDuet Sample Preparation system physically and data integrated with the BD   FACSLyric Flow Cytometer  \" FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution.  \" Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor   connections, addition of stabilization bracket (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.",
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    "name": "FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787    The K170974 clearance document describes the device as follows:    The BD FACSLyric\" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical   configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a   computer workstation. System options include an automated FACS Universal Loader and   a barcode reader.  The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part   of four available manufactured instrument configurations.  BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser  BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser  BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser  BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser  The lower level configurations are upgradeable to higher level configurations by adding   filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm   lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence   channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO).  All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in   height by 24.93 inches in width by 22.8 inches in depth.    The K201814 clearance document describes the device as follows:    Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer.  The modified BD FACSLyric Flow Cytometer consists of the following components.  \" FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations)  \" FACSuite Clinical Software (version 1.4)  \" Modified FACS Universal Loader: updated shaker and modification to the door lock and   sensor connections  \" Modified CMS firmware      BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system   consists of all the above components as FACSLyric Flow Cytometer and additionally contain:  \" BD FACSDuet Sample Preparation system physically and data integrated with the BD   FACSLyric Flow Cytometer  \" FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution.  \" Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor   connections, addition of stabilization bracket",
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      "name": "FDA recall Z-0748-2025: Becton, Dickinson and Company, BD Bio Sciences is recalling FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787    The K170974 clearance document describes the device as follows:    The BD FACSLyric\" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical   configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a   computer workstation. System options include an automated FACS Universal Loader and   a barcode reader.  The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part   of four available manufactured instrument configurations.  BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser  BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser  BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser  BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser  The lower level configurations are upgradeable to higher level configurations by adding   filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm   lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence   channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO).  All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in   height by 24.93 inches in width by 22.8 inches in depth.    The K201814 clearance document describes the device as follows:    Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer.  The modified BD FACSLyric Flow Cytometer consists of the following components.  \" FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations)  \" FACSuite Clinical Software (version 1.4)  \" Modified FACS Universal Loader: updated shaker and modification to the door lock and   sensor connections  \" Modified CMS firmware      BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system   consists of all the above components as FACSLyric Flow Cytometer and additionally contain:  \" BD FACSDuet Sample Preparation system physically and data integrated with the BD   FACSLyric Flow Cytometer  \" FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution.  \" Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor   connections, addition of stabilization bracket",
      "text": "The FDA logged enforcement record Z-0748-2025: Becton, Dickinson and Company, BD Bio Sciences is voluntarily recalling FACSLyric 3L10C Instrument US-IVD, Catalog Number 662878, UDI 00382906628787    The K170974 clearance document describes the device as follows:    The BD FACSLyric\" flow cytometer (3-1, 4-2, 4-2-2, and 4-3-3 optical   configurations) systems consist of a flow cytometer, sheath tank, waste tank, and a   computer workstation. System options include an automated FACS Universal Loader and   a barcode reader.  The BD FACSLyric Flow Cytometer includes the 488 nm laser and 640 nm laser as part   of four available manufactured instrument configurations.  BD FACSLyric Flow Cytometer, 3-1 configuration, 4-color/2-laser  BD FACSLyric Flow Cytometer, 4-2 configuration, 6-color/2-laser  BD FACSLyric Flow Cytometer, 4-2-2 configuration, 8-color/3-laser  BD FACSLyric Flow Cytometer, 4-3-3 configuration, 10-color/3-laser  The lower level configurations are upgradeable to higher level configurations by adding   filters, photomultiplier tubes (PMTs), and a laser. Only the 488 nm laser and 640 nm   lasers are utilized for cleared in vitro diagnostic (IVD) applications and only fluorescence   channels 1 (FL1) through FL6 are the subject of this 510(k) submission. Seven to tencolor immunophenotyping is for research use only (RUO).  All optical configurations of the FACSLyric share the same dimensions: 22.8 inches in   height by 24.93 inches in width by 22.8 inches in depth.    The K201814 clearance document describes the device as follows:    Refer to K170974 for detailed description and functioning of the BD FACSLyric flow cytometer.  The modified BD FACSLyric Flow Cytometer consists of the following components.  \" FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 ,4-3-3 and 4-3-5 optical configurations)  \" FACSuite Clinical Software (version 1.4)  \" Modified FACS Universal Loader: updated shaker and modification to the door lock and   sensor connections  \" Modified CMS firmware      BD FACSLyric Flow Cytometer with the integrated BD FACSDuet Sample Preparation system   consists of all the above components as FACSLyric Flow Cytometer and additionally contain:  \" BD FACSDuet Sample Preparation system physically and data integrated with the BD   FACSLyric Flow Cytometer  \" FACSDuet fluidics that contain saline, deionized (DI) water and 10% bleach solution.  \" Modified FACS Universal Loader: updated shaker, modification to the door lock and sensor   connections, addition of stabilization bracket — reason: On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure   on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-01. Affected lots/codes: Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted  Catalog Number: 662878 UDI-DI code: 00382906628787 Instrument Serial Numbers / Power Supply Serial Numbers: Z662878000426 V23180200 Z662878000412 V23180272 Z662878000410 V23180312 Z662878000046 UNK Z662878000319 UNK Z662878000367 V23090032 Z662878000373 V23090334 Z662878000370 V23090030 Z662878000371 V23090076 Z662878000377 V23090329 Z662878000369 V23090021 Z662878000375 V23090010 Z662878000372 V23090176 Z662878000378 V23090048 Z662878000380 V23090136 Z662878000374 V23090354 Z662878000383 V23090365 Z662878000379 V23090361 Z662878000401 V23180013 Z662878000382 V23090191 Z662878000381 V23090196 Z662878000421 V23180001 Z662878000387 V23090396 Z662878000420 V23180150 Z662878000425 V23180449 Z662878000399 V23180007 Z662878000400 V23090381 Z662878000422 V23090460 Z662878000386 V23090409 Z662878000388 V23090374 Z662878000390 V23090408 Z662878000368 V23090036 Z662878000431 V23300473 Z662878000432 V23300472 Z662878000389 V23090387 Z662878000423 V23180014 Z662878000454 V23300221 Z662878000413 V23180117 Z662878000376 V23090122 Z662878000455 V23300323 Z662878000453 V23300273 Z662878000411 V23180096 Z662878000385 V23090172 Z662878000384 V23090499 Z662878000394 V23090394 Z662878000395 V23180408 Z662878000434 V23180118 Z662878000435 V23300149 Z662878000111 UNK. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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      "commercialInfluence": false,
      "epistemicStatus": {
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      "grounding": {
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0748-2025&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0748-2025&lang=eng"
        }
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      "falsifier": "A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release."
    },
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      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0748-2025 as Class II",
      "text": "The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0748-2025&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0748-2025&lang=eng"
        }
      },
      "falsifier": "occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0748-2025/boundary",
      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "text": "A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "supported": true,
        "adjudged": false,
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "falsifier": "occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not."
    }
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            "Value": "Z-0748-2025",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Becton, Dickinson and Company, BD Bio Sciences",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "On October 18, 2024, BD has identified through customer complaints and an increase in field failures / replacements of the power supply module (part number 650781, Power Module AC-DC 250W 12/24V M3S4S6) on BD FACSLyric flow cytometers, which has the potential for the instruments to fail to power on and/or stay on. The potential power supply failure   on BD FACSLyric Flow Cytometer may lead to risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. The patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In addition, patient specimen loss and/ or delay providing results of testing results. There may be additional risks to the laboratory staff including inhalation of fumes followed by shortness of breath or coughing if failure occurs during laboratory working hours. In addition, the patient may be asked to return for additional biospecimen collection procedure and risks associated with the procedure (bruising, pain, bleeding, etc.). In the Notification Letter sent on November 20, 2024, customers are instructed to continue their normal operation of your BD FACSLyric Flow Cytometer according to the Instructions For Use after immediately inspecting inventory for the specific catalog and power supply serial numbers listed in the notification letter and follow the instructions listed under Actions for Clinical Users.",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Initiated",
            "Value": "2024-11-01",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted  Catalog Number: 662878 UDI-DI code: 00382906628787 Instrument Serial Numbers / Power Supply Serial Numbers: Z662878000426 V23180200 Z662878000412 V23180272 Z662878000410 V23180312 Z662878000046 UNK Z662878000319 UNK Z662878000367 V23090032 Z662878000373 V23090334 Z662878000370 V23090030 Z662878000371 V23090076 Z662878000377 V23090329 Z662878000369 V23090021 Z662878000375 V23090010 Z662878000372 V23090176 Z662878000378 V23090048 Z662878000380 V23090136 Z662878000374 V23090354 Z662878000383 V23090365 Z662878000379 V23090361 Z662878000401 V23180013 Z662878000382 V23090191 Z662878000381 V23090196 Z662878000421 V23180001 Z662878000387 V23090396 Z662878000420 V23180150 Z662878000425 V23180449 Z662878000399 V23180007 Z662878000400 V23090381 Z662878000422 V23090460 Z662878000386 V23090409 Z662878000388 V23090374 Z662878000390 V23090408 Z662878000368 V23090036 Z662878000431 V23300473 Z662878000432 V23300472 Z662878000389 V23090387 Z662878000423 V23180014 Z662878000454 V23300221 Z662878000413 V23180117 Z662878000376 V23090122 Z662878000455 V23300323 Z662878000453 V23300273 Z662878000411 V23180096 Z662878000385 V23090172 Z662878000384 V23090499 Z662878000394 V23090394 Z662878000395 V23180408 Z662878000434 V23180118 Z662878000435 V23300149 Z662878000111 UNK",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, Arkansas, California, Florida, Georgia, Illinois, Indiana, Iowa, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia & Wisconsin. The countries of China, Costa Rica, Singapore, Thailand.",
            "Status": "recorded"
          }
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}