OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSmart. 25 strips per vial. Product comes in packs of 100 and 50. (Part numbers: 020-245-07, 020-244-07, 020-963-01)
- Company
- Lifescan Inc
- Recall Initiated
- March 22, 2007
- Posted
- July 13, 2007
- Terminated
- August 15, 2008
- Recall Number
- Z-1042-2007
- Quantity
- ~33 million vials (25 strips per vial in the US, ~19 million worldwide.
- Firm Location
- Milpitas, CA
Reason for Recall
Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may produce inaccurately high or low blood glucose test results or error message readings.
Distribution
Worldwide; USA, Europe, Middle East, Africa, Latin America and Canada.
Lot / Code Info
Part numbers 020-245-07 (100 pack), 020-244-07 (50 pack), 020-963-01 (50 pack mail order). Expiration dates 08/2007 through 11/2008.
Root Cause
Other
Action Taken
March 2007 via letters to consumers and consignees and web postings. The firm has also set up verbal communication plans for customers who contact Lifescan by phone.
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