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  "name": "Alinity m System, Part Number: 08N53-002",
  "description": "FDA recall Z-1602-2024 — Abbott Molecular, Inc. is recalling Alinity m System, Part Number: 08N53-002 (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-1602-2024: Abbott Molecular, Inc. is recalling Alinity m System, Part Number: 08N53-002",
      "text": "The FDA logged enforcement record Z-1602-2024: Abbott Molecular, Inc. is voluntarily recalling Alinity m System, Part Number: 08N53-002 — reason: The Alinity m System camera detects whether tubes are \"capped.\" If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar.\"  Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-03-20. Affected lots/codes: Part Number: 08N53-002; UD/DI: 00884999048034.   Not Serial Number specific. A RECORDED FDA enforcement action (occurred=true).",
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      "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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      "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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