Ortho-Clinical recalls VITROS 4600 Chemistry Systems with software version 3.8.1 that may report incorrect patient test results due to a software defect.
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 4600 Chemistry Systems with specific software versions because a defect can cause incorrect patient test results. This affects laboratory equipment used for medical testing.
A software defect in version 3.8.1 prevents QC baseline statistics from updating correctly when changed by users. This can lead to incorrect patient test results being reported, potentially affecting medical decisions.
Laboratories using the VITROS 4600 Chemistry System with software version 3.8.1 are affected. Medical professionals and lab technicians who operate these systems are most at risk.
Check for the VITROS 4600 Chemistry System with catalog numbers 6802445 (regular) or 6900440 (refurbished). The software version 3.8.1 is also indicated by the serial numbers listed in the recall notice.
Verify the software version on your VITROS 4600 system to see if it is 3.8.1.
Software version 3.8.1 of the VITROS System.
Check the catalog number (6802445 for regular or 6900440 for refurbished) and software version 3.8.1.
The recall does not specify a remedy, so contact Ortho-Clinical for guidance.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1225-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1225-2024 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.
