Device recall
Z-0161-2020: xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral…
FDA device recall · Class II · Luminex Molecular Diagnostics
Key facts
| Recall number (Z-number) | Z-0161-2020 |
|---|---|
| Recall event | 83472 |
| Product | xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test |
| Product code | OCC |
| Recalling firm | Luminex Molecular Diagnostics |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K081483, K091667, K112199, K112781 |
| FEI number | 3002777243 |
At a glance
- 1–9 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