Device recall
Z-1962-2013: Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003…
FDA device recall · Class III · Remel Inc
Key facts
| Recall number (Z-number) | Z-1962-2013 |
|---|---|
| Recall event | 64711 |
| Product | Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a… |
| Product code | GNX |
| Recalling firm | Remel Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 14, 2013 |
| FEI number | 1924669 |
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