medical Class II Updated 2022-04-13

Abbott Laboratories recalls ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARC

Recalled Product

ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.

Hazard / Issue

This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: (01)00380740003272(17)220531(10)166000
View official government recall

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