Day

April 3, 2025
03
Apr

FDA Recall: Software Defect Leading to Issues with Calculated Results and Delay in Patient Results

April 3, 2025
Company: Beckman Coulter Inc. Date of Enforcement Report: 4/3/2025 Class II PRODUCT DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC)...
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