Device recall
Z-1328-06: Pointe Scientific Liquid Glucose (HEX) Reagent Set, for the quantitative…
FDA device recall · Class II · Pointe Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-1328-06 |
|---|---|
| Recall event | 35498 |
| Product | Pointe Scientific Liquid Glucose (HEX) Reagent Set, for the quantitative determination of glucose in serum, 10 x 5 ml R1 and 5 x 20 ml R2, or 9 x 67 ml R1and 9 x 17 ml R2 glucose reagent, for use with Hitachi analyzer; in vitro diagnostic, Catalog numbers HG720-600 and HG920-756. |
| Product code | CFR |
| Recalling firm | Pointe Scientific, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 19, 2007 |
| 510(k) numbers | K002199 |
| 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