Device recall
Z-2445-2012: Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code…
FDA device recall · Class III · Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Key facts
| Recall number (Z-number) | Z-2445-2012 |
|---|---|
| Recall event | 62440 |
| Product | Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera. |
| Product code | GQX |
| Recalling firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 24, 2016 |
| 510(k) numbers | K883427 |
| FEI number | 1318354 |
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