{
  "@context": {
    "schema": "https://schema.org/",
    "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#",
    "@vocab": "https://schema.org/",
    "claims": {
      "@id": "au:claims",
      "@container": "@list"
    },
    "epistemicStatus": "au:epistemicStatus",
    "occurred": "au:occurred",
    "supported": "au:supported",
    "adjudged": "au:adjudged",
    "operative": "au:operative",
    "grounding": "au:grounding",
    "groundingType": "au:groundingType",
    "adjudicator": "au:adjudicator",
    "source": "au:source",
    "sourceUrl": "au:sourceUrl",
    "value": "au:value",
    "claimType": "au:claimType",
    "reviewStatus": "au:reviewStatus",
    "commercialInfluence": "au:commercialInfluence",
    "falsifier": "au:falsifier"
  },
  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1476-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "cobas pro integrated solutions with cobas c 503 analytical units:    cobas pro sample supply unit, material number 08464502001  cobas pro SSU, material number 09205632001    Affected Assays:    (Product Name/ Catalog Number/ Application Code/ Application Short Name)    1. Cystatin C Gen.2 08105596190 20510 CYSC2  2. Ferritin Gen.4 08057648190 20571 FER4X  3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X  4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X  5. Vancomycin Gen.3 08058849190 21211 VANC3O  6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX  7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC  8. fCAL turbo Partner Channel 08910367190 21490 FCAL",
  "description": "FDA recall Z-1476-2026 — Roche Diagnostics Operations, Inc. is recalling cobas pro integrated solutions with cobas c 503 analytical units:    cobas pro sample supply unit, material number 08464502001  cobas pro SSU, material number 09205632001    Affected Assays:    (Product Name/ Catalog Number/ Application Code/ Application Short Name)    1. Cystatin C Gen.2 08105596190 20510 CYSC2  2. Ferritin Gen.4 08057648190 20571 FER4X  3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X  4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X  5. Vancomycin Gen.3 08058849190 21211 VANC3O  6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX  7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC  8. fCAL turbo Partner Channel 08910367190 21490 FCAL (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/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "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": {
      "@type": "schema:GovernmentOrganization",
      "name": "U.S. Food & Drug Administration"
    }
  },
  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1476-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "cobas pro integrated solutions with cobas c 503 analytical units:    cobas pro sample supply unit, material number 08464502001  cobas pro SSU, material number 09205632001    Affected Assays:    (Product Name/ Catalog Number/ Application Code/ Application Short Name)    1. Cystatin C Gen.2 08105596190 20510 CYSC2  2. Ferritin Gen.4 08057648190 20571 FER4X  3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X  4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X  5. Vancomycin Gen.3 08058849190 21211 VANC3O  6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX  7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC  8. fCAL turbo Partner Channel 08910367190 21490 FCAL",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Roche Diagnostics Operations, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1476-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1476-2026: Roche Diagnostics Operations, Inc. is recalling cobas pro integrated solutions with cobas c 503 analytical units:    cobas pro sample supply unit, material number 08464502001  cobas pro SSU, material number 09205632001    Affected Assays:    (Product Name/ Catalog Number/ Application Code/ Application Short Name)    1. Cystatin C Gen.2 08105596190 20510 CYSC2  2. Ferritin Gen.4 08057648190 20571 FER4X  3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X  4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X  5. Vancomycin Gen.3 08058849190 21211 VANC3O  6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX  7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC  8. fCAL turbo Partner Channel 08910367190 21490 FCAL",
      "text": "The FDA logged enforcement record Z-1476-2026: Roche Diagnostics Operations, Inc. is voluntarily recalling cobas pro integrated solutions with cobas c 503 analytical units:    cobas pro sample supply unit, material number 08464502001  cobas pro SSU, material number 09205632001    Affected Assays:    (Product Name/ Catalog Number/ Application Code/ Application Short Name)    1. Cystatin C Gen.2 08105596190 20510 CYSC2  2. Ferritin Gen.4 08057648190 20571 FER4X  3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X  4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X  5. Vancomycin Gen.3 08058849190 21211 VANC3O  6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX  7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC  8. fCAL turbo Partner Channel 08910367190 21490 FCAL — reason: Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-01-20. Affected lots/codes: cobas pro sample supply unit, UDI-DI 07613336158852 cobas pro SSU, UDI-DI 07613336179499  all software versions previous to 03-02. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "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-1476-2026&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-1476-2026&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1476-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1476-2026 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "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-1476-2026&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-1476-2026&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-1476-2026/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,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-1476-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1476-2026",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Roche Diagnostics Operations, Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2026-01-20",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "cobas pro sample supply unit, UDI-DI 07613336158852 cobas pro SSU, UDI-DI 07613336179499  all software versions previous to 03-02",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}