Device recall
Z-1503-2021: Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage…
FDA device recall · Class II · Clark Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-1503-2021 |
|---|---|
| Recall event | 87637 |
| Product | Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: intended for the qualitative detection of Measles igM antibodies in human serum of patients suspected of measles (rubeola) infection. |
| Product code | PCL |
| Recalling firm | Clark Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 29, 2022 |
| 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