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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1226-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)",
  "description": "FDA recall Z-1226-2024 — Ortho-Clinical Diagnostics, Inc. is recalling VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) (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": "VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)",
    "manufacturer": {
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      "name": "Ortho-Clinical Diagnostics, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1226-2024/enforcement-record",
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      "name": "FDA recall Z-1226-2024: Ortho-Clinical Diagnostics, Inc. is recalling VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)",
      "text": "The FDA logged enforcement record Z-1226-2024: Ortho-Clinical Diagnostics, Inc. is voluntarily recalling VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished) — reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user.  This may cause erroneous patient results to be reported.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-26. Affected lots/codes: VITROS System Software Version 3.8.1 Regular UDI-DI 10758750002740 Refurbished UD-DI 10758750007110  Serial Numbers  US: J56001885 J56003484 J56001886 J56003541 J56001910 J56003570 J56002308 J56003583 J56002461 J56003646 J56002474 J56003669 J56002608 J56003670 J56002698 J56004068 J56002704 J56004137 J56003342 J56004174 J56003356 J56004491 J56003377 J56004506 J56003433 J56004549 J56003477 J56004551 J56003478 J56004577   OUS: J56000425 J56002518 J56000512 J56002615 J56000533 J56002625 J56000674 J56002637 J56000680 J56002926 J56000719 J56002929 J56000809 J56003061 J56000831 J56003260 J56000836 J56003285 J56001051 J56003401 J56001111 J56003464 J56001114 J56003508 J56001208 J56003523 J56001731 J56003538 J56001765 J56004346 J56001826 J56004355 J56001853 J56004415 J56002085 J56004531 J56002116 J56004695. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
        "operative": 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-1226-2024&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-1226-2024&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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1226-2024/fda-classification",
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      "name": "FDA classified recall Z-1226-2024 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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        }
      },
      "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-1226-2024/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.",
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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-1226-2024",
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Ortho-Clinical Diagnostics, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user.  This may cause erroneous patient results to be reported.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-01-26",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "VITROS System Software Version 3.8.1 Regular UDI-DI 10758750002740 Refurbished UD-DI 10758750007110  Serial Numbers  US: J56001885 J56003484 J56001886 J56003541 J56001910 J56003570 J56002308 J56003583 J56002461 J56003646 J56002474 J56003669 J56002608 J56003670 J56002698 J56004068 J56002704 J56004137 J56003342 J56004174 J56003356 J56004491 J56003377 J56004506 J56003433 J56004549 J56003477 J56004551 J56003478 J56004577   OUS: J56000425 J56002518 J56000512 J56002615 J56000533 J56002625 J56000674 J56002637 J56000680 J56002926 J56000719 J56002929 J56000809 J56003061 J56000831 J56003260 J56000836 J56003285 J56001051 J56003401 J56001111 J56003464 J56001114 J56003508 J56001208 J56003523 J56001731 J56003538 J56001765 J56004346 J56001826 J56004355 J56001853 J56004415 J56002085 J56004531 J56002116 J56004695",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY,  LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.",
            "Status": "recorded"
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