OneTouch SureStep Glucose Test Strips (consumer use); OneTouch SureStep Pro Glucose Test Strips (hospital use)
This recall has been terminated (originally issued March 12, 2003).
- Company
- Lifescan Inc
- Recall Initiated
- January 13, 2003
- Posted
- March 12, 2003
- Terminated
- August 21, 2003
- Recall Number
- Z-0630-03
- Quantity
- 3,679,000 units
- Firm Location
- Milpitas, CA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Test Strips with Off-Center Confirmation Dot Part Number Lot Number Exp. Date Description 010-797-02, 191303A005, 10/03, SureStepPro Strips (50), 010-797-02, 192113A005, 10/03, SureStepPro Strips (50), 010-797-02, 194382A004, 11/03, SureStepPro Strips (50), 020-052-01, E-187250A, 9/03, 100-Count OneTouch SureStep Test Strips, 020-052-03, E-187250B, 9/03, 100-Count OneTouch SureStep Test Strips, 020-052-01, F-189831A, 9/03, 100-Count OneTouch SureStep Test Strips, 020-052-01, F-192063A, 10/03, 100-Count OneTouch SureStep Test Strips, 010-359-04, G-190477A, 10/03, 50-Count OneTouch SureStep Test Strips, 020-052-01, E-182852A, 5/03, 100-Count OneTouch SureStep Test Strips, Defective Test Strip Bottle Cap Part Number Lot Number Exp. Date Description 010-797-02, 205206A004, 02/04, 50-Count SureStepPro Test Strips, 010-797-02, 205913A012, 03/04, 50-Count SureStepPro Test Strips, 010-797-02, 205946A004, 03/04, 50-Count SureStepPro Test Strips, 020-052-02, F-204252B, 2/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-204296A, 1/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-204620A, 2/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-204668B, 2/04, 100-Count OneTouch SureStep Test Strips, 020-052-01, G-205519A, 3/04, 100-Count OneTouch SureStep Test Strips, 010-359-04, H-204583A, 12/03, 50-Count OneTouch SureStep Test Strips, 010-359-04, H-205890B, 3/04, 50-Count OneTouch SureStep Test, Strips ------------- F-204098B, 2/04, 50-Count OneTouch SureStep Medicare Test Strips
Root Cause
Other
Action Taken
Firm contacted all accounts by letters of 1/13/03 requesting replacement of the recall product.