Device recall
Z-1538-2021: For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2…
FDA device recall · Class I · INNOVA MEDICAL GROUP, INC.
Key facts
| Recall number (Z-number) | Z-1538-2021 |
|---|---|
| Recall event | 87682 |
| Product | For In Vitro Diagnostic Use Only *** 25T 888 SARS-CoV-2 Antigen *** SARS-CoV-2 Antigen Rapid Qualitative Test *** REF BT1309 |
| Product code | QKP |
| Recalling firm | INNOVA MEDICAL GROUP, INC. |
| Recall class | Class I |
| Status | Open, Classified |
| FEI number | 3018074194 |
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