Device recall
Z-2754-2020: BD MAX SARS-CoV-2 Reagents, Cat. No. 445003 (UDI 00382904450038) and 445003-01…
FDA device recall · Class II · Becton Dickinson & Co.
Key facts
| Recall number (Z-number) | Z-2754-2020 |
|---|---|
| Recall event | 86061 |
| 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… |
| Product code | QJR |
| Recalling firm | Becton Dickinson & Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 13, 2021 |
| FEI number | 1119779 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database