Device recall
Z-0743-2013: Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann…
FDA device recall · Class II · Alfa Wassermann, Inc.
Key facts
| Recall number (Z-number) | Z-0743-2013 |
|---|---|
| Recall event | 63866 |
| Product | Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006 Alfa Wassermann B.V. Pompmolenlaan 24 3447 GK, Woerden The Netherlands Common name is water solution. Intended to dilute reagents and rinse the parts of a… |
| Product code | CEO |
| Recalling firm | Alfa Wassermann, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2013 |
| 510(k) numbers | K103615 |
| FEI number | 1000122044 |
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