Device recall
Z-2310-2021: OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
FDA device recall · Class II · OPTI Medical Systems, Inc
Key facts
| Recall number (Z-number) | Z-2310-2021 |
|---|---|
| Recall event | 88344 |
| Product | OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004 |
| Product code | QJR |
| Recalling firm | OPTI Medical Systems, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3004102403 |
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