Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated Systems with software version 3.8.0 or higher. This version may not alert users when reagent packs expire, risking incorrect test results.
The VITROS 5600 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 5600 Integrated Systems with software version 3.8.0 or higher. These systems may not warn users when reagent packs expire, which could lead to using expired products and inaccurate test results.
The software version 3.8.0 may fail to notify users when the Signal Reagent Pack expires. Using expired reagents can cause the instrument to produce no results or incorrect test results, potentially affecting diagnostic accuracy.
Healthcare facilities using VITROS 5600 Integrated Systems with software version 3.8.0 or higher are most at risk. The recall affects systems installed since August 2008.
Check for VITROS 5600 Integrated Systems with model numbers 6802413 (New), 6802415 (Certified/Refurbished), or 6904001 (China). The software version must be 3.8.0 or higher. Systems were installed from August 2008 to present.
Install the latest software version to ensure proper expiration alerts for reagent packs.
The software version 3.8.0 may not correctly notify users if the Signal Reagent Pack expires, which could lead to using expired products and inaccurate test results.
VITROS 5600 Integrated Systems with model numbers 6802413 (New), 6802415 (Certified/Refurbished), or 6904001 (China) and software version 3.8.0 or higher.
Check the software version on your VITROS 5600 system. If it is 3.8.0 or higher, and your model number is 6802413, 6802415, or 6904001, you are affected.
We’ve drafted a message you can send VITROS to request your refund or repair — edit it as you like.
Subject: Recall Z-1005-2025 — VITROS VITROS Hello, I own a VITROS that is covered by recall Z-1005-2025 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.
