Device recall
Z-1202-2009: Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton…
FDA device recall · Class III · Pointe Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-1202-2009 |
|---|---|
| Recall event | 51042 |
| Product | Pointe Scientific Direct Bilirubin Reagent Set, Pointe Scientific Inc., Canton, MI. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers. |
| Product code | CIG |
| Recalling firm | Pointe Scientific, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 13, 2010 |
| 510(k) numbers | K040391 |
| 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