BEUDAMED
    FDA Recall Terminated

    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)

    Recall: Z-1042-2007 · Initiated March 22, 2007

    Recall

    Recall Number
    Z-1042-2007
    Event Number
    38016
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 22, 2007
    Posted
    July 13, 2007
    Terminated
    August 15, 2008
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035-6312

    Description

    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)

    Reason

    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.

    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.

    Distribution

    Worldwide; USA, Europe, Middle East, Africa, Latin America and Canada.

    Quantity

    ~33 million vials (25 strips per vial in the US, ~19 million worldwide.