Beckman Coulter is recalling 5,589 units of IRISPEC CA/CB/CC Urine Chemistry Controls because they can produce false positive results for glucose when used with certain iChemVELOCITY Urine Chemistry Strips on iChemVELOCITY Analyzers. This defect can lead to incorrect diagnostic readings or delays in reporting patient results. Such delays could impact the diagnosis or treatment of serious conditions including metabolic disorders, kidney function abnormalities, urinary tract infections, and liver issues.
The control solution may fail intermittently, causing the analyzer to incorrectly report a positive glucose result. This inaccuracy can lead to delayed or improper medical treatment for patients suffering from metabolic or renal disorders.
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Sources: FDA iRES · Raw API Response
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