Recall Z-2186-2021— Abbott Laboratories

Name: FDA recall Z-2186-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-10

Class II · Ongoing

Class II FDA medical device recall by Abbott Laboratories, initiated 2021-06-10. FDA's recall record names no specific 510(k) clearance for this event. Product: REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866. Reason: 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.

Recalling firm: Abbott Laboratories
Classification: Class II
Status: Ongoing
Initiated: 2021-06-10
Firm location: Irving, TX, United States

Product description

REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.