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...
Read More

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
office@softwarecpr.com
Partners located in the US (CA, FL, MA, MN, TX) and Canada.