Device recall
Z-0513-04: Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10…
FDA device recall · Class II · Diamedix Corporation
Key facts
| Recall number (Z-number) | Z-0513-04 |
|---|---|
| Recall event | 28083 |
| Product | Product is packaged in a box and is labeled: Syphilis TREP-CHEK No. 720-100-10, 960 test, For in Vitro Diagnostic Use Lot 71303 Exp. Jun 04 Diamedix, A subsidiary of IVAX Diagnostics, Inc. MIAMI, FL 33127 |
| Product code | LIP |
| Recalling firm | Diamedix Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2008 |
| 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