Device recall
Z-1397-06: Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml…
FDA device recall · Class II · Pointe Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-1397-06 |
|---|---|
| Recall event | 35496 |
| Product | Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent in 30 ml, 90 ml, 125 ml and 400 ml containers, sold by Pointe Scientific; Catalog nos. 7-A7516-R2-125, 7-A7516-R2-30, 7-A7516-R2-400ML, 7-A7516-R2-90, 8-A716-R2-125, 8-A7516-R2-30 and 8-A7516-R2-90. 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