Corrective action and recall of the AxSYM Ultrasensitive hTSH II Reagent from Abbott
2007.05.02
Product group In-vitro diagnostics
Reference 00877/07
Corrective action and recall of Abbott for AxSYM Ultrasensitive hTSH II Reagent (lot numbers 41762Q100, 46176Q101, 41762Q102, 41822Q100, 41822Q101, 42555Q100, 42555Q101, 42555Q102, 42555Q103, 44552Q100, 44552Q101, 44642Q101, 44642Q103, 44642Q104, 44642Q105, 44642Q106, 44642Q107, 46222Q100, 46222Q101, 46581Q100, 46582Q100, 47394Q100, 47394Q101, 47394Q102, 47454Q100, 48268Q100, 48483Q100, 48485Q100, 48485Q100, 48485Q101, 48553Q100, 48558Q101, 44913JN00, 49911JN00 and 49911JN01) because of calibration failures. Customers were informed about the problem and how to avoid it and were advised to discard the expired lots.