Device recall
Z-1946-2015: Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format…
FDA device recall · Class II · Axis-Shield Diagnostics, Ltd.
Key facts
| Recall number (Z-number) | Z-1946-2015 |
|---|---|
| Recall event | 70992 |
| Product | Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) Product Usage: For in-vitro… |
| Product code | LPS |
| Recalling firm | Axis-Shield Diagnostics, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 27, 2015 |
| 510(k) numbers | K083222 |
| FEI number | 3002808140 |
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