Abbott Laboratories recalls REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

Recalled August 3, 2022 · FDA recall Z-1455-2022 · Abbott Laboratories

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. · FDA Class II

Units

7,391 units

Sold at

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Description

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.

Product

REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

Manufacturer(s)

Abbott Laboratories

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →