Device recall
Z-0819-2015: Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF…
FDA device recall · Class III · Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Key facts
| Recall number (Z-number) | Z-0819-2015 |
|---|---|
| Recall event | 69827 |
| Product | Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of active syphilis in… |
| Product code | LIP |
| Recalling firm | Clark Laboratories, Inc. (dba,Trinity Biotech USA) |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 24, 2016 |
| 510(k) numbers | K904524 |
| 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