OneTouch SureStep Test Strips, Part numbers 020-052-01 and 010-359-04, for use with SureStep brand Blood Glucose Meters, manufactured by LifeScan Inc., Milpitas, CA
This recall has been terminated (originally issued March 17, 2009).
- Company
- Lifescan Inc
- Recall Initiated
- November 25, 2008
- Posted
- March 17, 2009
- Terminated
- December 6, 2010
- Recall Number
- Z-1070-2009
- Quantity
- 23,288 vials
- Firm Location
- Milpitas, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Deformity in the test strip may result in insufficient blood transfer to reaction area, resulting in inaccurate test results.
Distribution
Worldwide Distribution -- USA and the Caribbean.
Lot / Code Info
Lot codes 2802961 and 2802962
Root Cause
Process design
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.