Device recall
Z-1377-2012: Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles…
FDA device recall · Class III · Wako Chemicals USA, Inc.
Key facts
| Recall number (Z-number) | Z-1377-2012 |
|---|---|
| Recall event | 61084 |
| Product | Wako Autokit Lp(a) Calibrator, model code# 998-41491, packaged in 1 ml bottles, 2 bottles/kit, and labeled in part ***Manufactured by: Wako Pure Chemical Industries, Ltd. 1-2, Doshomachi 3-Chome, Chuo-Ku Osaka 540-8605, Japan***Distributed by: Wako Chemicals USA, Inc. /Wako Diagnostics 1600 Bellwood… |
| Product code | DFC |
| Recalling firm | Wako Chemicals USA, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 2, 2012 |
| 510(k) numbers | K981446 |
| 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