Class II — Becton Dickinson & Co.
| Recalling firm | Becton Dickinson and Company |
|---|---|
| Registered facility | View this company's 36 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 30,392 to date |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GU, HI, IL, IN, KY, MD, MI, MO, NC, NJ, NY, PA, SC, TN, TX, WI, WY and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Hong Kong, Japan, Mexico, New Zealand, Peru, Philippines, Singapore. |
| Initiated | 2020-07-20 |
| Classified | 2020-08-04 |
| Terminated | 2021-07-13 |
| Recall number | Z-2754-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Becton Dickinson & Co. (Z-2754-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86061/
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