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Abbott Laboratories Recall 88123

Description: REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866

Abbott Laboratories Recall 88123 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2187-2021
Event ID88123
Event DescriptionREF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866
Product TypeDevices
DistributionWorldwide 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.
Quantity2,212 units
Recall ReasonThere 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
Device Classification20210811
Device Code InfoLot Numbers / Expiration Date 84126UN20 / 09JUL2021 03676UN20 / 25AUG2021 10597UN20 / 29AUG2021 26275UN20 / 20OCT2021 77748UN20 / 08DEC2021 65958UN20 / 08DEC2021 81824UN21 / 16FEB2022
Center Classification Date20210802
Recall Initiation Date20210610
Recalling FirmAbbott Laboratories
Initial Notification Letter
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