BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Inten...
FDA Device Recall #Z-1682-2023 — Class II — May 1, 2023
Recall Summary
| Recall Number | Z-1682-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 1, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Becton Dickinson & Co. |
| Location | Sparks, MD |
| Product Type | Devices |
| Quantity | 70,948 EA |
Product Description
BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices- Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and/or B Catalog Number: 256088
Reason for Recall
IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,specifically describing specimen type, could cause use of the test with invalid specimen types, which may produce false positive or false negative results.Erroneous results can cause a delay in diagnosis or treatment
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of CA, CL, HK, TW.
Lot / Code Information
UDI-DI: N/A Lot Number Expiration Date 2077698 01-06-23; 2077708 05-06-23; 2209447 05-11-23; 2209462 09-11-23; 2212158 09-11-23; 2241596 09-11-23; 2242261 12-11-23; 2259433 15-11-23; 2259612 12-11-23; 2283876 10-01-24; 2332350 01-02-24; 2332352 07-03-24; 2340087 15-03-24; 2340090 16-03-24; 2348229 17-03-24; 2348238 22-03-24; 2348241 22-03-24; 2364051 10-04-24; 3003941 12-04-24; 3004372 14-04-24; 3009033 16-04-24; 3009036 16-04-24; 3009093 16-04-24; 3009985 16-04-24
Other Recalls from Becton Dickinson & Co.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0484-2026 | Class II | BD Kiestra" Isolate Suspension Cuvette Array; ... | Oct 23, 2025 |
| Z-0235-2026 | Class II | BD EpiCenter Microbiology Data Management Syste... | Sep 23, 2025 |
| Z-0236-2026 | Class II | BD BACTEC Blood Culture System, labeled as the ... | Sep 23, 2025 |
| Z-0240-2026 | Class II | BD Veritor Connect Software, labeled as the fol... | Sep 23, 2025 |
| Z-0237-2026 | Class II | BD BACTEC Blood Culture System, labeled as the ... | Sep 23, 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.