Recall Z-0630-03 ยท CGA Glucose Oxidase, Glucose
Lifescan Inc
OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)
| Date | Mar 12, 2003 (initiated Jan 13, 2003) |
| Status | Terminated |
| Reason | The Test Strips have manufacturing errors, in that the 'Confirmation Dot' is off-center or split in half, and defective bottle Cap. |
| Root cause | Other |
| Action | Firm contacted all accounts by letters of 1/13/03 requesting replacement of the recall product. |
| Quantity | 3,679,000 units |
| Distribution | Distribution of the product is worldwide and nationwide. Distribution in the United States was between April/02 to June/02. U.S. Government/Military or Canadian distribution is unknown at this time. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970556 | SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM Lifescan, Inc., May 12, 1997 |