Beckman Coulter Inc. recalls AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 1509959
Recalled Product
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Hazard / Issue
Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is only to the clinical interpretation of magnesium results in the presence of lipemia.
Issued by
FDA
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