Ortho-Clinical Diagnostics recalls VITROS XT 7600 Integrated Systems with software version 3.8.0 or higher that may not alert users when reagent packs expire, risking incorrect test results.
The VITROS XT 7600 Integrated 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 XT 7600 Integrated Systems with software version 3.8.0 or higher. These systems might not warn users when reagent packs expire, which could lead to using expired products and causing inaccurate test results.
The software may fail to notify users when the Signal Reagent Pack expires. Using expired reagents could cause the system to produce no results or incorrect test results, potentially affecting diagnostic accuracy.
Healthcare facilities using VITROS XT 7600 Integrated Systems with software version 3.8.0 or higher are likely affected. Laboratories using these systems for in vitro diagnostics face the highest risk.
Check for VITROS XT 7600 Integrated Systems with model numbers 6844461 (New), 6272222 (Certified), or 6904003 (China). The software version should be 3.8.0 or higher. Systems were distributed from July 2018 to present.
Verify the software version on your VITROS XT 7600 Integrated System. If it is 3.8.0 or higher, it is affected.
Software versions 3.8.0 or higher are affected.
Check for model numbers 6844461 (New), 6272222 (Certified), or 6904003 (China) with software version 3.8.0 or higher.
The recall does not specify a remedy, so contact Ortho-Clinical Diagnostics for guidance.
We’ve drafted a message you can send VITROS to request your refund or repair — edit it as you like.
Subject: Recall Z-1006-2025 — VITROS VITROS Hello, I own a VITROS that is covered by recall Z-1006-2025 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.
