Beckman Coulter Biomedical Division has recalled 2,754 units of AU/DxC AU Chemistry Transferrin reagent (Reference: OSR6152) because the product fails to meet stability standards while inside the testing machine. This defect can lead to incorrect high or low patient test results for serum, plasma, and urine samples, as well as testing equipment calibration failures. The manufacturer has received 2 safety reports and 99 quality complaints related to this issue, which was confirmed through internal testing. Consumers and laboratories should contact their healthcare provider or the manufacturer to discuss any impact on past medical testing.
The reagent can become unstable on the testing platform, causing inaccurate chemical measurements that lead to erroneous patient results. This poses a risk of misdiagnosis or delayed treatment if medical decisions are made based on the faulty laboratory data.
Product replacement and technical guidance
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.
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Sources: FDA iRES · Raw API Response
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