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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0026-2025.jsonld",
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  "name": "BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30-  IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place.  Catalog Number: 444150",
  "description": "FDA recall Z-0026-2025 — Becton Dickinson & Co. is recalling BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30-  IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place.  Catalog Number: 444150 (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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0026-2025&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30-  IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place.  Catalog Number: 444150",
    "manufacturer": {
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      "name": "Becton Dickinson & Co."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0026-2025/enforcement-record",
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      "name": "FDA recall Z-0026-2025: Becton Dickinson & Co. is recalling BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30-  IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place.  Catalog Number: 444150",
      "text": "The FDA logged enforcement record Z-0026-2025: Becton Dickinson & Co. is voluntarily recalling BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30-  IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place.  Catalog Number: 444150 — reason: Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy. Status: Ongoing — the recall is still being carried out.. Initiated 2024-09-12. Affected lots/codes: UDI-DI: 00382904441500 Software versions: 4.20, 4.30, 5.10, 5.20 and 5.30. A RECORDED FDA enforcement action (occurred=true).",
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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-0026-2025&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-0026-2025&lang=eng"
        }
      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0026-2025/fda-classification",
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      "name": "FDA classified recall Z-0026-2025 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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        }
      },
      "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-0026-2025/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",
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        "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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      "name": "FDA recall details — Z-0026-2025",
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Becton Dickinson & Co.",
            "Status": "recorded"
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            "Field": "Reason",
            "Value": "Synapsys software versions 4.20, 4.30, 5.10, 5.20, or 5.30 and utilizing the in-line breakpoint feature, an error is occurring where BD Synapsys will incorrectly display breakpoints for organisms that do not have defined breakpoints in CLSI or EUCAST. This occurs when the identified organism is included in the same interpretive group as a species for which there is a specific breakpoint. May result in either a false susceptible or false resistant result. A false susceptible result can cause inadequate or incomplete antibiotic treatment due to the use of an ineffective antibiotic, and a false resistant result may limit access to a preferred antibiotic regimen with possible elongation of therapy",
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            "Field": "Distribution pattern",
            "Value": "Nationwide Foreign: Australia, New Zealand, Singapore, Hong Kong, Taiwan, Japan, Austria, Belgium, Denmark, France, Germany, Italy, Luxembourg, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, Russia, Saudi Arabia, South Africa, Canada,  Mexico, China",
            "Status": "recorded"
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