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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0544-2024.jsonld",
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  "name": "VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0",
  "description": "FDA recall Z-0544-2024 — Ortho-Clinical Diagnostics, Inc. is recalling VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 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": "VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0544-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0544-2024: Ortho-Clinical Diagnostics, Inc. is recalling VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 Running Software Version 3.8.0",
      "text": "The FDA logged enforcement record Z-0544-2024: Ortho-Clinical Diagnostics, Inc. is voluntarily recalling VITROS 4600 Chemistry System Product Code 6802445 and Refurbished Product Code 6900440 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: 6802445,  UDI-DI: 10758750012343;  Product Code: 6900440,  UDI-DI: 10758750033201;  Serial Numbers: J46000208 J46000019 J46000861 J46000209 J46000020 J46000910 J46000240 J46000150 J46000983 J46000497 J46000162 J46001029 J46000864 J46000247 J46001041 J46000865 J46000296 J46001042 J46000898 J46000393 J46001119 J46001030 J46000410 J46001210 J46001064 J46000478 J46001217 J46001125 J46000499 J46001289 J46001132 J46000531 J46001541 J46001252 J46000564 J46001565 J46001293 J46000617 J46001609 J46001462 J46000772 J46001629 J46001703 J46000788 J46001639 J46001704 J46000800 J46001645  J46000820 J46001680  J46000859. A RECORDED FDA enforcement action (occurred=true).",
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        "supported": 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-0544-2024&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-0544-2024&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-0544-2024 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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0544-2024/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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      "epistemicStatus": {
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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
      },
      "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": "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: 6802445,  UDI-DI: 10758750012343;  Product Code: 6900440,  UDI-DI: 10758750033201;  Serial Numbers: J46000208 J46000019 J46000861 J46000209 J46000020 J46000910 J46000240 J46000150 J46000983 J46000497 J46000162 J46001029 J46000864 J46000247 J46001041 J46000865 J46000296 J46001042 J46000898 J46000393 J46001119 J46001030 J46000410 J46001210 J46001064 J46000478 J46001217 J46001125 J46000499 J46001289 J46001132 J46000531 J46001541 J46001252 J46000564 J46001565 J46001293 J46000617 J46001609 J46001462 J46000772 J46001629 J46001703 J46000788 J46001639 J46001704 J46000800 J46001645  J46000820 J46001680  J46000859",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide. Global Distribution.",
            "Status": "recorded"
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