OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)
FDA device recall Z-0630-03 · posted 2003-03-12 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- The Test Strips have manufacturing errors, in that the 'Confirmation Dot' is off-center or split in half, and defective bottle Cap.
- Action taken
- Firm contacted all accounts by letters of 1/13/03 requesting replacement of the recall product.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 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.
- Date initiated
- 2003-01-13
- Date posted
- 2003-03-12
- Date terminated
- 2003-08-21
- Location
- Milpitas, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEM (K970556) | Lifescan, Inc. | 1997-05-12 |