Ortho-Clinical recalls VITROS XT 7600 Integrated System software versions 3.8.0 and 3.8.1 due to a defect that may cause QC results to be accepted incorrectly, potentially leading to erroneous patient test results.
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
Ortho-Clinical is recalling VITROS XT 7600 Integrated Systems with specific software versions because a defect can cause quality control results to be accepted incorrectly. This may lead to patient test results that are not accurate, which could affect medical decisions.
A software defect in versions 3.8.0 and 3.8.1 causes the system to fail reporting Configurable Westgard Rules when new controls are defined. This may result in quality control results being accepted even when they don't meet required standards, potentially causing patient test results to be inaccurate.
Healthcare facilities using VITROS XT 7600 Integrated Systems with software versions 3.8.0 or 3.8.1 are most at risk, as the defect could lead to inaccurate patient test results.
Check if your VITROS XT 7600 Integrated System has software versions 3.8.0 or 3.8.1. The system's serial numbers and UDI-DI codes are listed in the recall notice for identification.
Verify your VITROS XT 7600 system's software version by checking the system settings or documentation.
Software versions 3.8.0 and 3.8.1 of the VITROS XT 7600 Integrated System.
The defect may cause quality control results to be accepted incorrectly, potentially leading to inaccurate patient test results.
The recall does not specify a remedy, so contact Ortho-Clinical for guidance on next steps.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1233-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1233-2024 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.
