Device recall
Z-1391-06: Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic Technologies…
FDA device recall · Class II · Pointe Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-1391-06 |
|---|---|
| Recall event | 35496 |
| Product | Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 8.4 mL and 30 mL containers. In vitro diagnostic. |
| Product code | CJE |
| Recalling firm | Pointe Scientific, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 19, 2007 |
| 510(k) numbers | K973588 |
| FEI number | 1827821 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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