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  "name": "Ringed DxI Reaction Vessels (RVs)",
  "description": "FDA recall Z-2237-2023 — Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) (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-2237-2023: Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs)",
      "text": "The FDA logged enforcement record Z-2237-2023: Beckman Coulter, Inc. is voluntarily recalling Ringed DxI Reaction Vessels (RVs) — reason: Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service test to evaluate washing efficiency. Increased relative light units (RLU) suspected to be caused by the resulting rough interior surface may lead to artificially falsely elevated results for susceptible tests, in particular, sandwich assays including, but not limited to, hsTnI, Hybritech p2PSA, IPTH/IPTH IO.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-06-20. Affected lots/codes: UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2237-2023 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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