Device recall
Z-1831-2013: uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries…
FDA device recall · Class II · Wako Life Sciences, Inc.
Key facts
| Recall number (Z-number) | Z-1831-2013 |
|---|---|
| Recall event | 65084 |
| Product | uTASWako DCP, Lot TG340 2013.11, REF 995-60701, Wako Pure Chemical Industries, Ltd. 1-2 Doshomachi 3-chome, Chuo-Ku Osaka 540-8605 Japan Distributed by Wako Diagnostics Wako Life Sciences, Inc. 1025 Terra Bella Ave., Suto A. Mountain View, CA 94043 USA. The product is a single reagent cartridge run… |
| Product code | DCF |
| Recalling firm | Wako Life Sciences, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2013 |
| 510(k) numbers | K100464 |
| FEI number | 3005625991 |
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