Device recall
Z-2782-2016: Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96…
FDA device recall · Class III · Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Key facts
| Recall number (Z-number) | Z-2782-2016 |
|---|---|
| Recall event | 74932 |
| Product | Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD |
| Product code | PCL |
| Recalling firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 9, 2017 |
| 510(k) numbers | K140455 |
| 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