Beckman Coulter Inc. has recalled 56,696 units of its Unsaturated Iron Binding Capacity (UIBC) assay kits, reference number OSR61205. The recall was initiated because internal testing revealed the kits do not meet their labeled claims for hemoglobin interference, which can result in inaccurate test results. Specifically, when blood samples have certain levels of hemoglobin (hemolysis), the UIBC readings may show a negative bias as high as -43.6%. While no injuries or incidents have been reported, these kits were distributed to medical laboratories and facilities that rely on them for patient testing.
The defect causes the diagnostic test to report significantly lower iron-binding capacity than what is actually present in a patient's sample. This could lead a healthcare provider to misdiagnose a patient's iron levels, potentially resulting in inappropriate or delayed medical treatment for iron-related conditions.
Quantity affected: 56,696 units. GTIN provided as (01)15099590011925.
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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