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FDAJune 9, 2022device

REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL

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

The hazard

There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.

What to do

FDA enforcement status: Ongoing

Brands named

abbott laboratoriesabbott

UPCs

00380740102746

Recall history

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

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