Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10 Hypoguard Advan
FDA device recall Z-0276-04 · posted 2003-12-25 · Terminated
Recall details
- Recalling firm
- Hypoguard USA, Inc.
- Reason for recall
- When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.
- Action taken
- The consignees were sent letters dated 11/26/03 which requested that the product be returned.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGA
- Distribution
- The product was distributed to consignees located nationwide in the United States.
- Date initiated
- 2003-11-26
- Date posted
- 2003-12-25
- Date terminated
- 2005-11-21
- Location
- Edina, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM (K020232) | Hypoguard USA, Inc. | 2002-02-12 |