Ortho-Clinical Diagnostics recalls VITROS 3600 Immunodiagnostic System versions 3.3.1 and below due to software anomaly that may incorrectly extend reagent stability time.
Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent.
Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic System versions 3.3.1 and below. This software issue could cause the system to incorrectly extend the stability time for loaded reagents, potentially leading to inaccurate test results.
The software anomaly may incorrectly extend the on-analyzer stability time for loaded reagents. This could lead to inaccurate test results if the reagents are used beyond their actual stability period. The risk is limited to the accuracy of test results rather than immediate safety hazards.
Healthcare facilities using the VITROS 3600 Immunodiagnostic System with software version 3.3.1 or below are affected. Laboratory staff and patients using this equipment for clinical testing are at risk of inaccurate results.
Check if your VITROS 3600 Immunodiagnostic System has software version 3.3.1 or below. Product codes 6802783 and 6802914, serial numbers J36000109-J36001169, and UDI numbers 10758750002979 and 10758750007103 are associated with this recall.
Verify your VITROS 3600 system's software version to ensure it is 3.3.1 or below.
The software anomaly may incorrectly extend the on-analyzer stability time for loaded reagents, potentially leading to inaccurate test results.
Check if your system has software version 3.3.1 or below, product codes 6802783 or 6802914, serial numbers J36000109-J36001169, or UDI numbers 10758750002979 or 10758750007103.
No, the recall does not require immediate discontinuation. The issue affects test accuracy, not immediate safety.
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-0652-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-0652-2019 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.
