Device recall
Z-2773-2015: Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro…
FDA device recall · Class III · Pointe Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-2773-2015 |
|---|---|
| Recall event | 71974 |
| Product | Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill. |
| Product code | CGX |
| Recalling firm | Pointe Scientific, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 29, 2015 |
| 510(k) numbers | K830556 |
| FEI number | 1827821 |
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