Device recall
Z-0699-2008: Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number…
FDA device recall · Class II · ARKRAY USA INC.
Key facts
| Recall number (Z-number) | Z-0699-2008 |
|---|---|
| Recall event | 45966 |
| Product | Assure 3 Blood Glucose Test Strips, For in vitro Diagnostic use. Product Number: 555050, Control Solution Range (mg/dL). Manufactured for Hypoguard, Minneapolis, MN 55439 USA. Made in Taiwan. |
| Product code | CGA |
| Recalling firm | ARKRAY USA INC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 30, 2008 |
| 510(k) numbers | K002621, K011233 |
| FEI number | 1832816 |
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