VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent gl...
FDA Device Recall #Z-1628-2023 — Class II — April 17, 2023
Recall Summary
| Recall Number | Z-1628-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 17, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ortho-Clinical Diagnostics, Inc. |
| Location | Raritan, NJ |
| Product Type | Devices |
| Quantity | 23751 |
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
Distribution Pattern
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
Lot / Code Information
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
Other Recalls from Ortho-Clinical Diagnostics, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2559-2025 | Class II | Chemistry Products LAC Slides. Catalog Number: ... | Jul 29, 2025 |
| Z-2560-2025 | Class II | VITROS Chemistry Products LAC Slides. Catalog N... | Jul 29, 2025 |
| Z-2335-2025 | Class II | VITROS Chemistry Products Ca Slides; Catalog N... | Jul 9, 2025 |
| Z-2073-2025 | Class II | VITROS Chemistry Products OP Reagent Gen 15. Mo... | Jun 12, 2025 |
| Z-2121-2025 | Class II | Brand Name: VITROS Chemistry Products Product ... | Jun 10, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.