Recall Z-1628-2023— Ortho-Clinical Diagnostics, Inc.

Name: FDA recall Z-1628-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-17

Class II · Ongoing

Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2023-04-17. It names one FDA 510(k) clearance: K142595. 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. Reason: Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis.

Recalling firm: Ortho-Clinical Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-04-17
Firm location: Raritan, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K142595 — VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and IIOrtho Clinical Diagnostics·cleared 2015-06-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.