Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated System software versions 3.4.1 and below due to potential luminometer malfunction causing inability to process MicroWell assays.
Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems
Ortho-Clinical Diagnostics is recalling software versions 3.4.1 and below for the VITROS XT 7600 Integrated System. This software issue may prevent the system from properly processing certain lab tests, which could lead to inaccurate results.
The software version 3.4.1 and below may cause the luminometer to malfunction, preventing the system from processing MicroWell assays correctly. This could lead to inaccurate test results if the system is used without the fix.
Lab users with the VITROS XT 7600 Integrated System software version 3.4.1 or below (product code 6844461) are affected. Healthcare facilities using this system for clinical testing are most at risk.
Check your VITROS XT 7600 Integrated System software version. Versions 3.4.1 and below (product code 6844461) are affected. Serial numbers 76000108 and above are included in this recall.
Download and install the latest software version from Ortho-Clinical Diagnostics to fix the luminometer issue.
Software versions 3.4.1 and below (product code 6844461) are affected.
Check your software version and product code. Affected units have serial numbers 76000108 and above.
The recall addresses potential inaccurate test results, not direct safety risks to users.
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-1291-2019 — Ortho-Clinical Diagnostics Ortho-Clinical Diagnostics Hello, I own a Ortho-Clinical Diagnostics that is covered by recall Z-1291-2019 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.
