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  "name": "VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)",
  "description": "FDA recall Z-1229-2024 — Ortho-Clinical Diagnostics, Inc. is recalling VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (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 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)",
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1229-2024/enforcement-record",
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      "name": "FDA recall Z-1229-2024: Ortho-Clinical Diagnostics, Inc. is recalling VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)",
      "text": "The FDA logged enforcement record Z-1229-2024: Ortho-Clinical Diagnostics, Inc. is voluntarily recalling VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (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 10758750002979 Refurbished UD-DI 10758750007103  Serial Numbers:  US: J36000109 J36000292 J36000489 J36000955 J36001167 J36001222 J36001283 J36001330 J36001348  OUS:  J36000148 J36001000 J36001495 J36000340 J36001012 J36001513 J36000348 J36001024 J36001515 J36000406 J36001026 J36001519 J36000407 J36001027 J36001528 J36000427 J36001051 J36001530 J36000446 J36001088 J36001535 J36000511 J36001108 J36001558 J36000517 J36001111 J36001570 J36000580 J36001112 J36001573 J36000612 J36001117 J36001575 J36000626 J36001154 J36001579 J36000688 J36001229 J36001581 J36000753 J36001237 J36001582 J36000861 J36001245 J36001583 J36000877 J36001246 J36001595 J36000920 J36001401 J36001600 J36000923 J36001403 J36001602 J36000929 J36001427 J36001608 J36000933 J36001451 J36001618 J36000941 J36001488 J36001632 J36000942 J36001489 J36001640. 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-1229-2024&lang=eng",
        "value": "Devices recall, status Ongoing",
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      "name": "FDA classified recall Z-1229-2024 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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        "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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1229-2024/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
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      "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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            "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 10758750002979 Refurbished UD-DI 10758750007103  Serial Numbers:  US: J36000109 J36000292 J36000489 J36000955 J36001167 J36001222 J36001283 J36001330 J36001348  OUS:  J36000148 J36001000 J36001495 J36000340 J36001012 J36001513 J36000348 J36001024 J36001515 J36000406 J36001026 J36001519 J36000407 J36001027 J36001528 J36000427 J36001051 J36001530 J36000446 J36001088 J36001535 J36000511 J36001108 J36001558 J36000517 J36001111 J36001570 J36000580 J36001112 J36001573 J36000612 J36001117 J36001575 J36000626 J36001154 J36001579 J36000688 J36001229 J36001581 J36000753 J36001237 J36001582 J36000861 J36001245 J36001583 J36000877 J36001246 J36001595 J36000920 J36001401 J36001600 J36000923 J36001403 J36001602 J36000929 J36001427 J36001608 J36000933 J36001451 J36001618 J36000941 J36001488 J36001632 J36000942 J36001489 J36001640",
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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.",
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