Device recall
Z-1139-2013: Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro…
FDA device recall · Class II · Alere San Diego, Inc.
Key facts
| Recall number (Z-number) | Z-1139-2013 |
|---|---|
| Recall event | 64671 |
| Product | Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST). |
| Product code | CKD |
| Recalling firm | Alere San Diego, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 13, 2013 |
| 510(k) numbers | K032027, K991834 |
| FEI number | 1000125596 |
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