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FDAApril 17, 2023device

VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905

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

The hazard

Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis

What to do

FDA enforcement status: Ongoing

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

10758750030729

Recall history

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

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