Device recall
Z-0373-04: Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and…
FDA device recall · Class III · Becton Dickinson & Co.
Key facts
| Recall number (Z-number) | Z-0373-04 |
|---|---|
| Recall event | 27995 |
| Product | Directigen (TM) EZ RSV In-Vitro Diagnostic test kit, containing reagents and controls for 30 tests, packaged in papercard carton. Catalog #256030. |
| Product code | GQG |
| Recalling firm | Becton Dickinson & Co. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 21, 2004 |
| 510(k) numbers | K022133 |
| FEI number | 1119779 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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