Ortho-Clinical Diagnostics recalls VITROS 3600 systems with software version 3.8.0 that may not detect expired reagent packs, risking incorrect test results.
The VITROS 3600 Immunodiagnostic System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.
Ortho-Clinical Diagnostics recalls VITROS 3600 Immunodiagnostic Systems with software version 3.8.0. These systems might not alert users when reagent packs expire, leading to potentially incorrect test results if expired products are used.
The software may fail to notify users when the Signal Reagent Pack expires. Using expired reagents could cause the test results to be inaccurate or no results at all, which might affect patient care decisions.
Healthcare facilities using VITROS 3600 systems with software version 3.8.0 or higher are affected. Laboratories using these systems for diagnostic testing are most at risk.
Check for VITROS 3600 Immunodiagnostic Systems with model numbers 6802783 (New), 6802914 (Certified/Refurbished), or 6904000 (China). Software version 3.8.0 or higher is the affected version.
Verify the software version on your VITROS 3600 system. If it is 3.8.0 or higher, it may be affected.
Software versions 3.8.0 or higher on the VITROS 3600 Immunodiagnostic System.
Check the model number (6802783, 6802914, or 6904000) and software version (3.8.0 or higher).
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send VITROS to request your refund or repair — edit it as you like.
Subject: Recall Z-1007-2025 — VITROS VITROS Hello, I own a VITROS that is covered by recall Z-1007-2025 from VITROS. 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.
