Ortho-Clinical recalls VITROS XT 3400 Chemistry System software versions 3.8.0 and 3.8.1 due to a defect that may cause incorrect patient test results. Affected units include specific serial numbers and catalog numbers.
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 3400 Chemistry Systems with specific software versions because a defect can cause patient test results to be reported incorrectly. This could lead to inaccurate medical decisions if the system is used without proper quality control checks.
A software defect in versions 3.8.0 and 3.8.1 causes the system to fail to properly flag quality control results. This means the system might accept test results that don't meet quality standards, potentially leading to incorrect patient test outcomes.
Laboratories using the VITROS XT 3400 Chemistry System with software versions 3.8.0 or 3.8.1 are affected. Lab technicians and medical staff who rely on these systems for patient testing are most at risk of potential errors.
Check if your VITROS XT 3400 Chemistry System has software version 3.8.0 or 3.8.1. Affected units include specific serial numbers listed in the recall notice and catalog number 6844458.
Verify your VITROS XT 3400 system's software version by checking the device settings or documentation.
The software defect causes the system to fail to report quality control results properly, which may lead to patient test results being reported incorrectly.
The recall does not specify a remedy, so contact Ortho-Clinical directly for guidance on next steps.
Check if your system has software version 3.8.0 or 3.8.1 and if your serial number is listed in the provided recall notice.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1232-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1232-2024 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.
