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Beckman Coulter Inc. recalls AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Recalled March 9, 2022 · FDA recall Z-0692-2022 · Beckman Coulter
Hazard
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. · FDA Class II
Units
181,776 Kits
Sold at
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Description
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.
Product
AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →