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  "name": "Alinity i Anti-TPO Reagent Kit, List Number 09P3521",
  "description": "FDA recall Z-1696-2023 — Abbott Ireland Limited is recalling Alinity i Anti-TPO Reagent Kit, List Number 09P3521 (Devices, Class III). 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": "FDA recall Z-1696-2023: Abbott Ireland Limited is recalling Alinity i Anti-TPO Reagent Kit, List Number 09P3521",
      "text": "The FDA logged enforcement record Z-1696-2023: Abbott Ireland Limited is voluntarily recalling Alinity i Anti-TPO Reagent Kit, List Number 09P3521 — reason: Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).. Status: Ongoing — the recall is still being carried out.. Initiated 2023-04-24. Affected lots/codes: UDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-1696-2023 as Class III",
      "text": "The FDA assigned this recall Class III: Class III — the FDA judged the product is unlikely to cause 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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      "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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      "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": "Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).",
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            "Field": "Distribution pattern",
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