Day

June 27, 2025
27
Jun

FDA Recall: Software anomaly treats system as expired

June 27, 2025
Company: Ortho-Clinical Diagnostics, Inc. Date of Enforcement Report: 6/27/2025 Class: II PRODUCT Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915 Recall Number: Z-2038-2025 REASON: A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even...
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