Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated System versions 3.3.1 and below due to software anomaly that may incorrectly extend reagent stability time, potentially affecting test accuracy.
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System versions 3.3.1 and below because a software issue could incorrectly extend the stability time for loaded reagents. This might lead to inaccurate test results if the reagents are used beyond their actual shelf life.
The software anomaly may cause the system to show reagents as stable longer than they actually are. This could lead to using reagents that have expired, resulting in inaccurate test results for patient care.
Laboratories using the VITROS 5600 Integrated System with software version 3.3.1 or below are affected. Laboratory staff and healthcare providers who perform clinical testing with these systems are most at risk of inaccurate results.
Check if your VITROS 5600 system has software version 3.3.1 or below. Product codes include 6802413 (UDI 10758750002740) and 6802915 (refurbished, UDI 10758750007110).
Verify your VITROS 5600 system's software version to ensure it is not 3.3.1 or below.
Contact Ortho-Clinical Diagnostics to update to a newer software version that resolves this issue.
Software versions 3.3.1 and below are affected.
Check the product code and serial numbers listed in the recall notice, which include specific UDI and serial number ranges.
Contact Ortho-Clinical Diagnostics to update your software to a newer version that resolves this issue.
We’ve drafted a message you can send Ortho-Clinical Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0650-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0650-2019 from Ortho-Clinical Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
