Device recall
Z-0458-2008: Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number…
FDA device recall · Class III · ARKRAY USA INC.
Key facts
| Recall number (Z-number) | Z-0458-2008 |
|---|---|
| Recall event | 45483 |
| Product | Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro Diagnostic Use, Manufactured for ARKRAY USA, Inc., Minneapolis, MN 55439 USA. (Package Contents -Advance Micro-draw Blood Glucose Meter, 10 test Strips, Codeing chip and Control Solution (3mL)… |
| Product code | CGA |
| Recalling firm | ARKRAY USA INC. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 2, 2008 |
| FEI number | 1832816 |
At a glance
- None 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