Device recall
Z-1416-2021: BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the…
FDA device recall · Class II · Becton Dickinson & Co.
Key facts
| Recall number (Z-number) | Z-1416-2021 |
|---|---|
| Recall event | 87605 |
| Product | BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213 |
| Product code | QJR |
| Recalling firm | Becton Dickinson & Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 2, 2022 |
| 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