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  "name": "Alinity ci-series System Control Module, REF: 03R70-01",
  "description": "FDA recall Z-0613-2024 — Abbott Laboratories is recalling Alinity ci-series System Control Module, REF: 03R70-01 (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-0613-2024: Abbott Laboratories is recalling Alinity ci-series System Control Module, REF: 03R70-01",
      "text": "The FDA logged enforcement record Z-0613-2024: Abbott Laboratories is voluntarily recalling Alinity ci-series System Control Module, REF: 03R70-01 — reason: There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-30. Affected lots/codes: UDI-DI: 00380740137410.  Software Version 3.4.0 and lower.. A RECORDED FDA enforcement action (occurred=true).",
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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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