Device recall
Z-1041-2010: Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set…
FDA device recall · Class II · Pointe Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-1041-2010 |
|---|---|
| Recall event | 53784 |
| Product | Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC902-576 and HC902-1000. Calcium Reagent Set for repackaging, Catalog # HC902-SAM-911. The product is used for the quantitative determination of calcium in serum on Hitachi… |
| Product code | CIC |
| Recalling firm | Pointe Scientific, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 10, 2010 |
| 510(k) numbers | K822469 |
| 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