BD SARS-CoV-2 Reagents for BD MAX" Systems — Class II medical device recall Z-2023-2024
Ongoing recall by Becton Dickinson & Co., reported 2024-06-12, distributed nationwide. Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
| Recall number | Z-2023-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2024-05-07 |
| Classified | 2024-06-05 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Quantity | 2,061 kits |
| UPC / GTIN / UDI-DI | 60382904450030 |
| Lot numbers | 3291356 |
| Model numbers | 445003-01 |
| Expiration dates | 2024-08-03, 2024-11-19, 2024-12-17 |
Product
BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.
Reason for recall
Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing.
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-2023-2024. 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.