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Abbott Laboratories recalls REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
Recalled August 11, 2021 · FDA recall Z-2185-2021 · Abbott Laboratories
Hazard
There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results · FDA Class II
Units
1,603 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of VA, UT, TX, TN, SD,PA, NY, ME, ID, CA and the countries of AFGHANISTAN, AUSTRALIA, AUSTRIA, BAHAMAS, BANGLADESH, BELGIUM, BOSNIA AND HERZEGOVI, CANADA, CAYMAN ISLANDS, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FAROE ISLAND, FINLAND, FRANCE, GERMANY, GREENLAND, Hong Kong, INDIA, IRELAND, ISRAEL, ITALY, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, MONTENEGRO, NETHERLANDS, NORWAY, OMAN, PAKISTAN, PANAMA, PHILIPPINES, PORTUGAL, PR CHINA, REPUBLIC OF YEMEN, ROMANIA, RUSSIA, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD & TOBAGO, UNITED KINGDOM, VIETNAM.
Description
There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results
Product
REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859
Manufacturer(s)
Abbott Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →