Device recall
Z-1464-2015: DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product…
FDA device recall · Class II · Diasorin Inc.
Key facts
| Recall number (Z-number) | Z-1464-2015 |
|---|---|
| Recall event | 70773 |
| Product | DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product Usage: The PRO-Trac II Tacrolimus ELISA kit is an in vitro reagent system intended for the quantitative determination of tacrolimus (Prografl, FK506) and some metabolites in human EDT A or heparinized whole blood as an aid… |
| Product code | MLM |
| Recalling firm | Diasorin Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2015 |
| PMA numbers | P970025 |
| FEI number | 2182595 |
At a glance
- None 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