Recall Z-0275-04 ยท CGA Glucose Oxidase, Glucose
Hypoguard USA, Inc.
Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.
| Date | Dec 25, 2003 (initiated Nov 26, 2003) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | The consignees were sent letters dated 11/26/03 which requested that the product be returned. |
| Quantity | 10-count bottles 6336; 50-count bottles 73,490; and 100-count bottles 221 |
| Distribution | The product was distributed to consignees located nationwide in the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020232 | HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM Hypoguard USA, Inc., Feb 12, 2002 |