BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B — Class II medical device recall Z-1682-2023
Ongoing recall by Becton Dickinson & Co., reported 2023-06-14, distributed nationwide. IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic
| Recall number | Z-1682-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2023-05-01 |
| Classified | 2023-06-02 |
| Reported by FDA | 2023-06-14 |
| Distributed | Nationwide (US) |
| Quantity | 70,948 units |
| Reason classes | unapproved product |
| Lot numbers | 14-04-24, 15-03-24, 15-11-23, 16-03-24, 16-04-24, 17-03-24, 2077698, 2077708, 22-03-24, 2209447, 2209462, 2212158, 2241596, 2242261, 2259433, 2259612, 2283876, 2332350, 2332352, 2340087, 2340090, 2348229, 2348238, 2348241, 2364051, 3003941, 3004372, 3009033, 3009036, 3009093, 3009985 |
| Model numbers | 256088 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1682-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.