Ortho-Clinical recalls VITROS 3600 Immunodiagnostic Systems with specific software versions due to a defect that may cause incorrect patient test results. Affected units include catalog numbers 6802783 and 6802914.
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 3600 Immunodiagnostic Systems with software versions 3.8.0 and 3.8.1 because a defect can cause QC results to be accepted when they shouldn't be, potentially leading to incorrect patient test results. This affects specific catalog numbers and serial numbers listed in the recall.
A software defect in versions 3.8.0 and 3.8.1 causes the system to fail in reporting when QC results meet statistical criteria. This means the system might accept QC results that don't meet quality standards, which could lead to incorrect patient test results.
Healthcare facilities using the VITROS 3600 system with the specified software versions and catalog numbers are most at risk. Patients may be affected if their tests are run on faulty equipment.
Check if your VITROS 3600 system has catalog numbers 6802783 (regular) or 6802914 (refurbished) and software versions 3.8.0 or 3.8.1. Serial numbers listed in the recall include US and OUS numbers starting with J3600.
Verify your VITROS system's software version by checking the device settings or documentation.
Reach out to Ortho-Clinical Diagnostics for assistance with the recall process.
Software versions 3.8.0 and 3.8.1 are affected.
Check for catalog numbers 6802783 (regular) or 6802914 (refurbished) and software versions 3.8.0 or 3.8.1. Serial numbers starting with J3600 are listed in the recall.
The recall does not require immediate stop use; contact Ortho-Clinical for guidance.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1229-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1229-2024 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.
