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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0543-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0",
  "description": "FDA recall Z-0543-2024 — Ortho-Clinical Diagnostics, Inc. is recalling VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0 (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-0543-2024&lang=eng",
  "about": {
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    "name": "VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0",
    "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-0543-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0543-2024: Ortho-Clinical Diagnostics, Inc. is recalling VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0",
      "text": "The FDA logged enforcement record Z-0543-2024: Ortho-Clinical Diagnostics, Inc. is voluntarily recalling VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version 3.8.0 — reason: During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-10-10. Affected lots/codes: Product Code: 6802783,  UDI-DI: 10758750002979;  Product Code: 6802914,  UDI-DI: 10758750007103;  Serial Numbers: J36000109 J36000294 J36001012 J36001489 J36000292 J36000340 J36001024 J36001495 J36000484 J36000348 J36001027 J36001513 J36000489 J36000446 J36001051 J36001515 J36000955 J36000511 J36001088 J36001519 J36001151 J36000517 J36001108 J36001528 J36001167 J36000580 J36001111 J36001535 J36001222 J36000688 J36001112 J36001570 J36001283 J36000753 J36001117 J36001573 J36001330 J36000861 J36001237 J36001575 J36001348 J36000877 J36001245 J36001579  J36000920 J36001246 J36001581  J36000923 J36001401 J36001582  J36000929 J36001403 J36001583  J36000933 J36001427 J36001600  J36000941 J36001451 J36001602  J36000942 J36001488 J36001618  J36001000. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": 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-0543-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "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-0543-2024&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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      "name": "FDA classified recall Z-0543-2024 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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        "adjudged": true,
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        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
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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-0543-2024/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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      "reviewStatus": "current",
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      "epistemicStatus": {
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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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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
            "Value": "Ortho-Clinical Diagnostics, Inc.",
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            "Field": "Reason",
            "Value": "During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive subsystems, unresponsive user interface (sometimes referred to as a screen freeze), and/or printer disconnections was identified. The consequence of these issues would be a delay in reporting results due to the required system shutdowns to recover the system. This delay in reporting results could occur during any assay, including which the speed of the result is deemed critical or STAT and could result in a delay of treatment in a patient. Due to the release strategy of this software version, the user could not update the system but a field engineer had to manually install each affected system.",
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            "Value": "Product Code: 6802783,  UDI-DI: 10758750002979;  Product Code: 6802914,  UDI-DI: 10758750007103;  Serial Numbers: J36000109 J36000294 J36001012 J36001489 J36000292 J36000340 J36001024 J36001495 J36000484 J36000348 J36001027 J36001513 J36000489 J36000446 J36001051 J36001515 J36000955 J36000511 J36001088 J36001519 J36001151 J36000517 J36001108 J36001528 J36001167 J36000580 J36001111 J36001535 J36001222 J36000688 J36001112 J36001570 J36001283 J36000753 J36001117 J36001573 J36001330 J36000861 J36001237 J36001575 J36001348 J36000877 J36001245 J36001579  J36000920 J36001246 J36001581  J36000923 J36001401 J36001582  J36000929 J36001403 J36001583  J36000933 J36001427 J36001600  J36000941 J36001451 J36001602  J36000942 J36001488 J36001618  J36001000",
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            "Field": "Distribution pattern",
            "Value": "US Nationwide. Global Distribution.",
            "Status": "recorded"
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