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August 5, 2025
05
Aug

FDA Recall: Software anomaly causes increased PnP motion errors

August 5, 2025
Company: Beckman Coulter, Inc. Date of Enforcement Report: 8/5/2025 Class: II PRODUCT UniCel DxI 800 Access Immunoassay Analyzer, Part Number 973100 Recall Number: Z-2266-2025 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...
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