Ortho-Clinical recalls VITROS 4600 Chemistry Systems with specific software versions due to a defect that may cause incorrect patient test results. Affected units include catalog numbers 6802445 and 6900440 with serial numbers listed.
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 4600 Chemistry Systems with software versions 3.8.0 or 3.8.1 because a defect can cause test results to be reported incorrectly. This means some patient results might be inaccurate 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 in reporting quality control results. This means the system might accept results that don't meet quality standards, potentially leading to incorrect patient test outcomes.
Healthcare facilities using the VITROS 4600 Chemistry System with specific software versions and catalog numbers are affected. Laboratory staff and patients who receive tests from these systems may be at risk of inaccurate results.
Check for VITROS 4600 Chemistry Systems with catalog numbers 6802445 (regular) or 6900440 (refurbished). The software version should be 3.8.0 or 3.8.1. Serial numbers listed in the recall include US and OUS codes starting with J4600.
Verify the software version on your VITROS 4600 system; affected versions are 3.8.0 or 3.8.1.
Reach out to Ortho-Clinical Diagnostics for guidance on next steps if your system is affected.
Software versions 3.8.0 and 3.8.1 on the VITROS 4600 Chemistry System.
Check for catalog numbers 6802445 (regular) or 6900440 (refurbished) and software versions 3.8.0 or 3.8.1. Serial numbers starting with J4600 are listed in the recall.
Contact Ortho-Clinical Diagnostics for specific instructions; the recall does not include a direct remedy.
We’ve drafted a message you can send Ortho-Clinical to request your refund or repair — edit it as you like.
Subject: Recall Z-1230-2024 — Ortho-Clinical Ortho-Clinical Hello, I own a Ortho-Clinical that is covered by recall Z-1230-2024 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.
