Ortho-Clinical Diagnostics recalls VITROS 5600 Integrated Systems with specific software versions 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 Diagnostics is recalling VITROS 5600 Integrated Systems with software versions 3.8.0 and 3.8.1. This software defect may cause the system to accept QC results that don't meet quality standards, which could lead to incorrect patient test results.
A software defect in the VITROS Systems running versions 3.8.0 and 3.8.1 causes configurable Westgard Rules to not report properly when new controls are defined. This may result in the system accepting QC results that don't meet quality standards, potentially leading to incorrect patient test results.
Healthcare facilities using the VITROS 5600 Integrated System with software versions 3.8.0 or 3.8.1 are affected. Laboratory staff and patients using these systems may be at risk of receiving incorrect test results.
Check if your VITROS 5600 Integrated System has catalog numbers 6802413 (regular) or 6802915 (refurbished) and software versions 3.8.0 or 3.8.1. Serial numbers listed in the recall notice indicate affected units.
Verify your VITROS 5600 system's software version by checking the system settings or documentation.
Contact Ortho-Clinical Diagnostics to update to a corrected software version if your system is affected.
Software versions 3.8.0 and 3.8.1 of the VITROS 5600 Integrated System are affected.
Check your system's catalog number (6802413 for regular or 6802915 for refurbished) and software version. Affected units have specific serial numbers listed in the recall notice.
Contact Ortho-Clinical Diagnostics to update to a corrected software version. The recall does not require immediate discontinuation of use.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1231-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1231-2024 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.
