Ortho-Clinical recalls VITROS XT 7600 Integrated System software version 3.8.1 due to QC baseline statistics not updating correctly, potentially causing inaccurate patient test results.
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 7600 Integrated Systems with software version 3.8.1 because a defect may cause patient test results to be inaccurate. This affects laboratory equipment used for medical testing.
A software defect in version 3.8.1 prevents QC baseline statistics from updating properly when changed by the user. This could lead to inaccurate patient test results if the system is not functioning correctly.
Laboratories using the VITROS XT 7600 Integrated System with software version 3.8.1 are affected. Lab technicians and healthcare providers who rely on this equipment for patient testing are most at risk.
Check if your VITROS XT 7600 Integrated System has software version 3.8.1. The system's serial numbers are listed in the recall notice, including US and OUS serial numbers.
Verify your VITROS XT 7600 system's software version to see if it is 3.8.1.
Yes, if your VITROS XT 7600 Integrated System has software version 3.8.1, it is affected by this recall.
Check your system's serial number against the list provided in the recall notice, which includes US and OUS serial numbers.
The recall does not specify a remedy, so you should check the official notice for further instructions.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1228-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1228-2024 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.
