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Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (
Recalled May 31, 2023 · FDA recall Z-1628-2023 · Ortho-Clinical Diagnostics
Hazard
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis · FDA Class II
Units
23751
Sold at
US Nationwide- Worldwide Distribution. Foreign: Australia Belgium Brazil Bermuda HM12 Canada L3R 4G5 Chile China Colombia Denmark France France Germany India Italy Japan Mexico Norway Portugal Russia Singapore 609917 Spain Sweden The Netherlands United Kingdom
Description
Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
Product
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
Manufacturer(s)
Ortho-Clinical Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →