Device recall
Z-0899-2010: Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of…
FDA device recall · Class II · Pointe Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-0899-2010 |
|---|---|
| Recall event | 53872 |
| Product | Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding capacity, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7504-60, I7504-400, I7504-SAM, 10-I7504-60. Clinical chemistry reagent for the quantitative determination of iron in serum. |
| Product code | JIY |
| Recalling firm | Pointe Scientific, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 6, 2011 |
| 510(k) numbers | K864882 |
| 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