Device recall
Z-0452-2022: Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number…
FDA device recall · Class II · Biomeme, Inc.
Key facts
| Recall number (Z-number) | Z-0452-2022 |
|---|---|
| Recall event | 89064 |
| Product | Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564 |
| Product code | QJR |
| Recalling firm | Biomeme, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 5, 2024 |
| FEI number | 3014117298 |
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