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  "name": "DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461",
  "description": "FDA recall Z-2270-2025 — Beckman Coulter, Inc. is recalling DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 (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-2270-2025: Beckman Coulter, Inc. is recalling DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461",
      "text": "The FDA logged enforcement record Z-2270-2025: Beckman Coulter, Inc. is voluntarily recalling DxI 600 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71461 — reason: Beckman Coulter has identified that the UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings where the PnP X-motor current incorrectly resets to 1.5A (instead of the required 2.0A) because the software overwrites the factory setting during installs or upgrades. This anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-06-25. Affected lots/codes: UDI-DI: 15099590369248; Serial Numbers: 902101. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2270-2025 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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      "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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