Abbott GmbH FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35Class IIMar 4, 2024Customer complaints were received regarding falsely elevated	Customer complaints were received regarding falsely elevated results for some patient samples. Internal studie	Class IIDevices	Mar 4, 2024
Alinity i Anti-HCV Reagent Kit, List Number 08P0521Class IIMar 4, 2024Customer complaints were received regarding falsely elevated	Customer complaints were received regarding falsely elevated results for some patient samples. Internal studie	Class IIDevices	Mar 4, 2024