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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2121-2025.jsonld",
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  "name": "Brand Name: VITROS Chemistry Products  Product Name: VITROS Chemistry Products Performance Verifier II  Model/Catalog Number: 8231474  Software Version: N/A  Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.    VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added.  Component: No, not a component",
  "description": "FDA recall Z-2121-2025 — Ortho-Clinical Diagnostics, Inc. is recalling Brand Name: VITROS Chemistry Products  Product Name: VITROS Chemistry Products Performance Verifier II  Model/Catalog Number: 8231474  Software Version: N/A  Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.    VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added.  Component: No, not a component (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",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2121-2025&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "Brand Name: VITROS Chemistry Products  Product Name: VITROS Chemistry Products Performance Verifier II  Model/Catalog Number: 8231474  Software Version: N/A  Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.    VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added.  Component: No, not a component",
    "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-2121-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2121-2025: Ortho-Clinical Diagnostics, Inc. is recalling Brand Name: VITROS Chemistry Products  Product Name: VITROS Chemistry Products Performance Verifier II  Model/Catalog Number: 8231474  Software Version: N/A  Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.    VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added.  Component: No, not a component",
      "text": "The FDA logged enforcement record Z-2121-2025: Ortho-Clinical Diagnostics, Inc. is voluntarily recalling Brand Name: VITROS Chemistry Products  Product Name: VITROS Chemistry Products Performance Verifier II  Model/Catalog Number: 8231474  Software Version: N/A  Product Description: VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.    VITROS Performance Verifier is prepared from processed human serum to which enzymes, electrolytes, stabilizers,mpreservatives and other organic analytes have been added.  Component: No, not a component — reason: Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).. Status: Ongoing — the recall is still being carried out.. Initiated 2025-06-10. Affected lots/codes: Lot Code: Product Code: 823 1474 (UDI: 10758750004577)  Lots currently within expiry:  W1667- Exp. 8/14/2025 X1901 - Exp. 11/20/2025 A2114 - Exp. 3/25/2026 D2338 - Exp. 6/3/2026 F2830 - Exp. 2/3/2027. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2121-2025&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-2121-2025 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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      "@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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        "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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      "name": "FDA recall details — Z-2121-2025",
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            "Value": "Z-2121-2025",
            "Status": "recorded"
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          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Value": "Ortho-Clinical Diagnostics, Inc.",
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            "Field": "Reason",
            "Value": "Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).",
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          "item": {
            "Field": "Initiated",
            "Value": "2025-06-10",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "Lot Code: Product Code: 823 1474 (UDI: 10758750004577)  Lots currently within expiry:  W1667- Exp. 8/14/2025 X1901 - Exp. 11/20/2025 A2114 - Exp. 3/25/2026 D2338 - Exp. 6/3/2026 F2830 - Exp. 2/3/2027",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, GA, IL, MD, MI, MO, MS, NY, TN, TX, VA; and OUS (International) to countries of: Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and United Kingdom.",
            "Status": "recorded"
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