FDA-Device2021-08-11Class II
REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866
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
Sold states
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.
Affected count
36 units
Manufactured in
1915 Hurd Dr, Irving, TX, United States
Products
REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2186-2021Don't want to check this manually?
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