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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1026-2026.jsonld",
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  "name": "Beckman Coulter UniCel Dxl 800, Part numbers:  973100, A71456, A71457, A25288; \tImmunoassay Method, Troponin Subunit",
  "description": "FDA recall Z-1026-2026 — Beckman Coulter, Inc. is recalling Beckman Coulter UniCel Dxl 800, Part numbers:  973100, A71456, A71457, A25288; \tImmunoassay Method, Troponin Subunit (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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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1026-2026&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "Beckman Coulter UniCel Dxl 800, Part numbers:  973100, A71456, A71457, A25288; \tImmunoassay Method, Troponin Subunit",
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      "name": "Beckman Coulter, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1026-2026/enforcement-record",
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      "name": "FDA recall Z-1026-2026: Beckman Coulter, Inc. is recalling Beckman Coulter UniCel Dxl 800, Part numbers:  973100, A71456, A71457, A25288; \tImmunoassay Method, Troponin Subunit",
      "text": "The FDA logged enforcement record Z-1026-2026: Beckman Coulter, Inc. is voluntarily recalling Beckman Coulter UniCel Dxl 800, Part numbers:  973100, A71456, A71457, A25288; \tImmunoassay Method, Troponin Subunit — reason: Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-11-26. Affected lots/codes: 973100:  UDI 15099590265373 (Chaska) and 16954701000412 (Suzhou);  A71456:  UDI 15099590369194;  A71457:  UDI 15099590369231;  A25288:  UDI 15099590194819. A RECORDED FDA enforcement action (occurred=true).",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": 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-1026-2026&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-1026-2026&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-1026-2026/fda-classification",
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      "name": "FDA classified recall Z-1026-2026 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.",
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1026-2026/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,
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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-1026-2026",
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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Beckman Coulter, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-11-26",
            "Status": "recorded"
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          "item": {
            "Field": "Lot/code info",
            "Value": "973100:  UDI 15099590265373 (Chaska) and 16954701000412 (Suzhou);  A71456:  UDI 15099590369194;  A71457:  UDI 15099590369231;  A25288:  UDI 15099590194819",
            "Status": "recorded"
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        },
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Cabo Verde, Canada, Chile, China, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Egypt, El Salvador, Eswatini, Ethiopia, France, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lebanon, Libya, Lithuania, Malaysia, Mayotte, Mexico, Moldova, Republic of, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, North Macedonia, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Viet Nam, and Zimbabwe.",
            "Status": "recorded"
          }
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