Beckman Coulter Inc. is recalling 12,102 units of IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent (REF 447610). The manufacturer identified two specific lots of reagents that do not meet the sensitivity standards stated in the Instructions for Use (IFU). Because this reagent is used to quantitatively measure immunoglobulin M levels in human serum, results may be less accurate than required for clinical diagnosis. This recall affects various states and international locations where the diagnostic equipment is used in clinical laboratories.
The reduced sensitivity of the reagent may lead to inaccurate measurement of immunoglobulin M (IGM) in patient samples. This could result in incorrect diagnostic data, potentially affecting medical decisions or treatments based on those laboratory results.
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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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