Device recall
Z-0784-05: Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by…
FDA device recall · Class III · Diasorin Inc.
Key facts
| Recall number (Z-number) | Z-0784-05 |
|---|---|
| Recall event | 31710 |
| Product | Trep-Chek Syphilis Test Kit, 960 tests, Catalog No. TP-960, Distributed by DiaSorin, Inc. 1951 Northwestern Ave, Stillwater, MN 55082-0285 USA. Manufactured by Phoenix Bio-Tech Corp., 6910 Kitimat Road, Unit #1, Mississauga, Ontario, Canada L5N 5M2. |
| Product code | LIP |
| Recalling firm | Diasorin Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 22, 2006 |
| 510(k) numbers | K001552 |
| FEI number | 2182595 |
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