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FDAMarch 8, 2022device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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).

What to do

FDA enforcement status: Ongoing

Brands named

abbott laboratoriesabbott

UPCs

00380740003272

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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