Device recall
Z-0572-2014: Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the…
FDA device recall · Class II · Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Key facts
| Recall number (Z-number) | Z-0572-2014 |
|---|---|
| Recall event | 66916 |
| Product | Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It… |
| Product code | LIP |
| Recalling firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 24, 2016 |
| 510(k) numbers | K104233 |
| FEI number | 1318354 |
At a glance
- 1–9 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