Device recall
Z-1530-2014: Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage…
FDA device recall · Class II · Alfa Wassermann, Inc.
Key facts
| Recall number (Z-number) | Z-1530-2014 |
|---|---|
| Recall event | 67897 |
| Product | Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office… |
| Product code | CIT |
| Recalling firm | Alfa Wassermann, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 13, 2015 |
| 510(k) numbers | K113382 |
| FEI number | 1000122044 |
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