Ortho-Clinical recalls VITROS XT 3400 Chemistry System software version 3.8.1 due to potential erroneous patient results from QC baseline statistics not updating correctly.
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 XT 3400 Chemistry Systems with software version 3.8.1 because this defect may cause incorrect patient test results. Users should update to a fixed software version to prevent errors.
A software defect in version 3.8.1 prevents QC baseline statistics from updating properly when changed by users. This can lead to incorrect patient test results if the system reports outdated data.
Healthcare facilities using the VITROS XT 3400 Chemistry System with software version 3.8.1 are affected. Laboratory staff and patients using this system for blood tests are at risk of incorrect results.
Check for the VITROS XT 3400 Chemistry System with software version 3.8.1. Serial numbers listed include US: J34500180, J34500289, and others.
Install the corrected software version to ensure QC baseline statistics update properly.
Software version 3.8.1 of the VITROS System.
Check for the VITROS XT 3400 Chemistry System with serial numbers listed in the recall notice, including US: J34500180, J34500289, and others.
Yes, updating to a corrected software version resolves the issue.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1227-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1227-2024 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.
