FDA Recall
Terminated
Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10 Hypoguard Advance Blood Glucose Strips
Recall: Z-0276-04
·
Initiated November 26, 2003
Recall
- Recall Number
- Z-0276-04
- Event Number
- 27760
- Firm
- Hypoguard USA, Inc.
- FEI Number
- 1832816
- Product Code
- CGA
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 26, 2003
- Posted
- December 25, 2003
- Terminated
- November 21, 2005
- Address
- 5182 W 76th St, Edina, MN, 55439-2900
Description
Hypoguard Advance Blood Glucose Monitoring System, includes Hypoguard Advance Blood Glucose Meter and 10 Hypoguard Advance Blood Glucose Strips
Reason
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
The consignees were sent letters dated 11/26/03 which requested that the product be returned.
Distribution
The product was distributed to consignees located nationwide in the United States.