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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1230-2024.jsonld",
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  "name": "VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)",
  "description": "FDA recall Z-1230-2024 — Ortho-Clinical Diagnostics, Inc. is recalling VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (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 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1230-2024/enforcement-record",
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      "name": "FDA recall Z-1230-2024: Ortho-Clinical Diagnostics, Inc. is recalling VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)",
      "text": "The FDA logged enforcement record Z-1230-2024: Ortho-Clinical Diagnostics, Inc. is voluntarily recalling VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) — reason: A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected.  When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met.  This may result in acceptance of QC results that do not meet acceptance criteria, which 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 Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201  Serial Numbers:  US:  J46000208 J46000209 J46000240 J46000497 J46000864 J46000865 J46000898 J46001030 J46001064 J46001125 J46001132 J46001293 J46001462 J46001703 J46001704   OUS:  J46000150 J46000933 J46000162 J46001029 J46000190 J46001041 J46000247 J46001042 J46000296 J46001087 J46000393 J46001119 J46000410 J46001186 J46000478 J46001187 J46000499 J46001210 J46000531 J46001217 J46000564 J46001289 J46000617 J46001541 J46000772 J46001565 J46000788 J46001571 J46000800 J46001609 J46000801 J46001629 J46000812 J46001639 J46000821 J46001645 J46000855 J46001680 J46000859 J46000948 J46000861 J46000983 J46000910. A RECORDED FDA enforcement action (occurred=true).",
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        "supported": true,
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1230-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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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-1230-2024 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-1230-2024/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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            "Value": "Ortho-Clinical Diagnostics, Inc.",
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            "Field": "Reason",
            "Value": "A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected.  When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met.  This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.",
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            "Value": "VITROS System Software Versions 3.8.0 or 3.8.1 Regular UDI-DI 10758750012343 Refurbished UD-DI 10758750033201  Serial Numbers:  US:  J46000208 J46000209 J46000240 J46000497 J46000864 J46000865 J46000898 J46001030 J46001064 J46001125 J46001132 J46001293 J46001462 J46001703 J46001704   OUS:  J46000150 J46000933 J46000162 J46001029 J46000190 J46001041 J46000247 J46001042 J46000296 J46001087 J46000393 J46001119 J46000410 J46001186 J46000478 J46001187 J46000499 J46001210 J46000531 J46001217 J46000564 J46001289 J46000617 J46001541 J46000772 J46001565 J46000788 J46001571 J46000800 J46001609 J46000801 J46001629 J46000812 J46001639 J46000821 J46001645 J46000855 J46001680 J46000859 J46000948 J46000861 J46000983 J46000910",
            "Status": "recorded"
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            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil,  Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.",
            "Status": "recorded"
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