OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters,
FDA device recall Z-1070-2009 · posted 2009-03-17 · Terminated
Recall details
- Recalling firm
- Lifescan Inc
- Reason for recall
- Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
- Action taken
- Urgent: Medical Device Recall letters, dated 11/24/2008 were issued to all consignees on November 25, 2008, requesting return of affected lots to LifeScan and instructing how to obtain replacement strips free of charge. A request for sub-recall communications were made as well, and the firm posted notification on its website. Customer service and Sales account reps were provided information to address questions regarding the recall.
- Root cause
- Process design
- Status
- Terminated
- Product code
- NBW
- Quantity affected
- 23,288 vials
- Distribution
- Worldwide Distribution -- USA and the Caribbean.
- Date initiated
- 2008-11-25
- Date posted
- 2009-03-17
- Date terminated
- 2010-12-06
- Location
- Milpitas, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURESTEP BLOOD GLUCOSE MONITORING SYSTEM (K022724) | Lifescan, Inc. | 2002-09-12 |