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  "name": "Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2",
  "description": "FDA recall Z-2428-2024 — Beckman Coulter Inc. is recalling Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 (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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      "name": "FDA recall Z-2428-2024: Beckman Coulter Inc. is recalling Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2",
      "text": "The FDA logged enforcement record Z-2428-2024: Beckman Coulter Inc. is voluntarily recalling Beckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2 — reason: LIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to report as normal. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-27. Affected lots/codes: UDI: 15099590011598/ All Lots: 2548/Exp. 2024-06-01, 2549/Exp.2024-10-01, 2550/Exp. 2024-11-01, 2551/Exp. 2025-04-01, 2552/Exp. 2025-07-01, 2553/Exp. 2025-10-01, 2554/ Exp. 2026-03-01. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2428-2024 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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      "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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