Ortho-Clinical recalls VITROS 5600 Integrated Systems with specific software versions due to a defect that may cause incorrect patient test results. Affected units include regular and refurbished models with listed serial numbers.
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
Ortho-Clinical is recalling VITROS 5600 Integrated Systems with software version 3.8.1 because a defect can cause patient test results to be reported incorrectly. This affects specific models and serial numbers sold in the U.S. and other regions.
A software defect in version 3.8.1 prevents QC baseline statistics from updating correctly when changed by the user. This may lead to patient test results being reported incorrectly, though the exact impact on health outcomes isn't specified.
Healthcare facilities using the VITROS 5600 Integrated System with software version 3.8.1 are most at risk. Patients receiving tests from these systems could potentially get inaccurate results.
Check if your VITROS 5600 system has catalog numbers 6802413 (regular) or 6802915 (refurbished) and software version 3.8.1. Serial numbers listed in the recall notice include both U.S. and other region codes.
Verify your VITROS system's software version; if it is 3.8.1, it may be affected.
Software version 3.8.1 is affected.
Regular model catalog number 6802413 and refurbished model catalog number 6802915.
Check if your system has the listed serial numbers in the recall notice, which include both U.S. and other region codes.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1226-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1226-2024 from Ortho-Clinical. 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.
