Device recall
Z-0325-05: The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme…
FDA device recall · Class III · Diamedix Corporation
Key facts
| Recall number (Z-number) | Z-0325-05 |
|---|---|
| Recall event | 30165 |
| Product | The Is-Syphilis TREP-CHEK (TM) Test Kit is a confirmatory in vitro enzyme immunoassay for the qualitative detection of Treponema pallidum IgG antibodies in human serum or plasma. The reagents can be used either manually or in conjunction with the MAGO Plus or APTUS Automated EIA Processors. The FDA… |
| Product code | LIP |
| Recalling firm | Diamedix Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 5, 2009 |
| 510(k) numbers | K001552 |
| FEI number | 1044713 |
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