Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1628-2023 — 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

U.S. FDA — Device Enforcement · United States · 2023-04-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1628-2023
Date of alert
2023-04-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ortho-Clinical Diagnostics, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10758750030729
Reported risk: Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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