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  "name": "FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770    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-0747-2025 — Becton, Dickinson and Company, BD Bio Sciences is recalling FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770    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 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770    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-0747-2025: Becton, Dickinson and Company, BD Bio Sciences is recalling FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770    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-0747-2025: Becton, Dickinson and Company, BD Bio Sciences is voluntarily recalling FACSLyric 3L8C Instrument US-IVD, Catalog Number 662877, UDI 00382906628770    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: 662877 UDI-DI code: 00382906628770 Instrument Serial Numbers / Power Supply Serial Numbers: Z662877000064 V23180197 Z662877000053 V23090166 Z662877000052 V23090305 Z662877000054 V23090341 Z662877000051 V23090060 Z662877000056 V23090037 Z662877000058 V23090446 Z662877000055 V23090190 Z662877000061 V23180242 Z662877000057 V23090456 Z662877000060 V23180454 Z662877000065 V23180453 Z662877000062 V23300158 Z662877000063 V23300110 Z662877000059 V23180441 Z662877000068 V23300012. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0747-2025/fda-classification",
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      "name": "FDA classified recall Z-0747-2025 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.",
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        "value": "Class II",
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        }
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      "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."
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      "@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",
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
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      "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": "Ongoing — the recall is still being carried out.",
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            "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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            "Field": "Initiated",
            "Value": "2024-11-01",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Power supply part number 650781 with serial numbers beginning with V2309, V2318, and V2330 are impacted  Catalog Number: 662877 UDI-DI code: 00382906628770 Instrument Serial Numbers / Power Supply Serial Numbers: Z662877000064 V23180197 Z662877000053 V23090166 Z662877000052 V23090305 Z662877000054 V23090341 Z662877000051 V23090060 Z662877000056 V23090037 Z662877000058 V23090446 Z662877000055 V23090190 Z662877000061 V23180242 Z662877000057 V23090456 Z662877000060 V23180454 Z662877000065 V23180453 Z662877000062 V23300158 Z662877000063 V23300110 Z662877000059 V23180441 Z662877000068 V23300012",
            "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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