Recall Z-1628-2023 ยท PDJ Hemoglobin A1c Test System
Ortho-Clinical Diagnostics, Inc.
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
| Date | May 24, 2023 (initiated Apr 17, 2023) |
| Status | Open, Classified |
| Reason | Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis |
| Root cause | Under Investigation by firm |
| Action | Ortho Clinical Diagnostics (Ortho) issued to Dealers and End-Users Urgent Product Correction Notification Potential Bias Observed in VITROS Chemistry Products HbA1c Reagent Kit on 4/17/23. Letter states reason for recall, health risk and action to take: In an abundance of caution, the required actions are applicable to all lots within expiry ( as well as future lots until your laboratory receives an additional notification from Ortho. However, while data is limited, a review of the release testing indicated no other lots were impacted. Reagent Pack Used for Calibration o If your system current |
| Quantity | 23751 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142595 | VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verif Ortho Clinical Diagnostics, Jun 4, 2015 |