Recalling Firm / Manufacturer

Lifescan Inc

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)

Code Information

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 of 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.

Date Recall Initiated

March 22, 2007

Action

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. Firm Initiated recall is ongoing.

Contact

Source of Information

U.S FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.