Device recall
Z-1419-05: PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL…
FDA device recall · Class II · Diagnostica Stago, Inc.
Key facts
| Recall number (Z-number) | Z-1419-05 |
|---|---|
| Recall event | 32494 |
| Product | PTT-LA. Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL.. Distributed in the USA by: Diagnostica Stago, Inc., Five Century Drive, Parsippany, NJ 07054. |
| Product code | GGW |
| Recalling firm | Diagnostica Stago, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 3, 2006 |
| 510(k) numbers | K921684 |
| FEI number | 2245451 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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