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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2129-2023.jsonld",
  "@type": "schema:Dataset",
  "name": "VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only.  VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.  Product Code: 6801704",
  "description": "FDA recall Z-2129-2023 — Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only.  VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.  Product Code: 6801704 (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.",
  "license": "https://creativecommons.org/publicdomain/zero/1.0/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2129-2023&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only.  VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.  Product Code: 6801704",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Ortho-Clinical Diagnostics"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2129-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2129-2023: Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only.  VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.  Product Code: 6801704",
      "text": "The FDA logged enforcement record Z-2129-2023: Ortho-Clinical Diagnostics is voluntarily recalling VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only.  VITROS Chemistry Products Calibrator Kit 20- Used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of transferrin, C3, C4, IgA, IgG and IgM.  Product Code: 6801704 — reason: Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM.  Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-08. Affected lots/codes: UDI-DI: 10758750006687 Lot Code: 2022 Exp. Date :06-Sept-2023. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "SourceCitation",
        "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-2129-2023&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "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-2129-2023&lang=eng"
        }
      },
      "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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2129-2023/fda-classification",
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      "name": "FDA classified recall Z-2129-2023 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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        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2129-2023&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2129-2023&lang=eng"
        }
      },
      "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-2129-2023/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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
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        "adjudged": false,
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        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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-2129-2023",
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            "Value": "Z-2129-2023",
            "Status": "recorded"
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Ortho-Clinical Diagnostics",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential to cause biased results in the upper end of the reportable range for the quantitative measurement of Transferrin, C3, C4, IgA, IgG and IgM.  Within the reference interval, the highest bias observed in selected sample testing investigation was +35.3% for IgM; -4.3% for IgG; +12.3% for IgA; -6.9% for C3; -6.6% for C4; and -17.8% for transferrin. Falsely elevated or reduced results could be reported depending on the analyte and/or sample concentration.",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2023-05-08",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI: 10758750006687 Lot Code: 2022 Exp. Date :06-Sept-2023",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 4G5, Chile, China, Colombia, Denmark, France, Germany,  India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden ,  The Netherlands, United Kingdom.",
            "Status": "recorded"
          }
        }
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