Ortho-Clinical Diagnostics is recalling approximately 487,461 units of VITROS Chemistry Products Performance Verifiers and CHE Slides. The recall was initiated because the quality control (QC) results may drift and become inaccurate between 2 and 7 days after the testing fluids are prepared (reconstituted), even though labels claim stability for 7 days. This defect can lead to slightly higher patient test results than actual or cause delays in treatment while labs repeat testing or prepare new fluids. Laboratory staff should contact the manufacturer or their distributor to arrange for a replacement or correction.
The drift in quality control results can lead to a small positive bias in patient test results, potentially resulting in incorrect clinical assessments. Additionally, the need to repeat tests when quality control fails can delay critical results for patients.
Used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 and VITROS 5600/XT 7600 Chemistry Systems.
Used to monitor performance on VITROS 250/350/5,1 FS/4600/XT 3400 and VITROS 5600/XT 7600 Chemistry Systems.
Used for cholinesterase enzyme (CHE) testing.
Distributed in Japan.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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