Beckman Coulter has recalled 70 units of its Access Testosterone assay (Catalog Number 33560) due to a manufacturing defect that can cause inaccurate test results. Maintenance issues on the fill line caused cross-contamination in certain reagent packs, which may result in patient testosterone levels being reported as up to 34% higher or 23% lower than the actual value. No injuries or incorrect treatments have been reported at this time. Laboratory personnel should stop using the affected lot and contact the manufacturer to arrange for replacement or correction.
Inaccurate testosterone results can lead to medical misdiagnosis or inappropriate treatment plans. The splashing between reagent wells during the filling process creates a risk that test results will be significantly higher or lower than the patient's actual testosterone levels.
Affected by splashing/cross-contamination on the RPL5 fill line.
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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