FDA Device recall Z-1628-2023
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol…
- FDA Device
- Class II
- ongoing
- Published 2023-05-31
On 2023-05-31 the FDA classified a Class II recall of VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol… by Ortho Clinical Diagnostics, citing potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1628-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-17 |
| Published | 2023-05-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
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
Identifiers
| code_info | UDI-DI: 10758750030729 Lot Number/Expiry: 29-9396 2023-SEP-02; 29-9466 2023-SEP-02; 30-9647 2023-NOV-25; 30-9803 2023-N…UDI-DI: 10758750030729 Lot Number/Expiry: 29-9396 2023-SEP-02; 29-9466 2023-SEP-02; 30-9647 2023-NOV-25; 30-9803 2023-NOV-25; 31-9648 2024-JAN-24; 32-9925 2024-APR-14; 33-1097 2024-JUL-18; 33-1105 2024-JUL-18; 33-1228 2024-JUL-18; 34-1345* 2024-OCT-17. All lots within expiry (listed above) as well as future lots until your laboratory receives an additional notification from Ortho |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1628-2023%22
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