BD MAX SARS-CoV-2 Reagents — Class II medical device recall Z-2754-2020
Terminated recall by Becton Dickinson & Co., reported 2020-08-12, distributed nationwide. BD is experiencing elevated rates of potential false positive results from certain customers when using the BD
| Recall number | Z-2754-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Becton Dickinson & Co., Sparks, MD, United States |
| Recall initiated | 2020-07-20 |
| Classified | 2020-08-04 |
| Reported by FDA | 2020-08-12 |
| Terminated | 2021-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BR, CA, CL, CO, HK, JP, MX, NZ, PE, PH, SG |
| Quantity | 30,392 to |
| UPC / GTIN / UDI-DI | 00382904450038, 60382904450030 |
| Model numbers | 445003 |
Product
BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01 (UDI (01)603829044500301) - Product Usage: intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal, nasal, mid-turbinate, and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal aspirates obtained from individuals suspected of COVID-19 by their healthcare provider.
Reason for recall
BD is experiencing elevated rates of potential false positive results from certain customers when using the BD SARS-CoV-2 Reagents for the BD MAX System. False positive test results could lead to a delay in diagnosis and potentially cause the patient to be exposed to COVID-19 if they are isolated with an infected individual.
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-2754-2020. 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.