Recall Z-1042-2007
Lifescan Inc · initiated March 22, 2007
Product
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)
Codes / lots: 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.
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.
FDA-determined 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.
Details
- Recall number
- Z-1042-2007
- Initiated
- March 22, 2007
- Posted by FDA
- July 13, 2007
- Terminated
- August 15, 2008
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Quantity
- ~33 million vials (25 strips per vial in the US, ~19 million worldwide.
- Distribution
- Worldwide; USA, Europe, Middle East, Africa, Latin America and Canada.
- Recalling firm
- Lifescan Inc, Milpitas, CA