Beckman Coulter Ireland, Inc. is recalling 36,981 units of its Bicarbonate reagents (catalog numbers OSR6137, OSR6237, and OSR6637) used on AU clinical analyzers. The reagents may produce falsely high bicarbonate test results because they can interact incorrectly with Lactate Dehydrogenase (LDH) in a patient's serum or plasma sample. Because of this potential for diagnostic error, laboratories should stop using the affected reagents to ensure patient safety and data accuracy.
A falsely high bicarbonate result could lead healthcare providers to misinterpret a patient's acid-base balance, potentially leading to inappropriate medical treatments or delayed diagnoses. No specific injuries or deaths have been reported, but inaccurate lab results pose a moderate risk to patient management.
System reagent for the quantitative determination of Bicarbonate in human serum and plasma.
System reagent for the quantitative determination of Bicarbonate in human serum and plasma.
System reagent for the quantitative determination of Bicarbonate in human serum and plasma.
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.
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Sources: FDA iRES · Raw API Response
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