BEUDAMED
    FDA Recall Terminated

    LifeScan brand OneTouch FastTake Blood Glucose Meter

    Recall: Z-0822-05 · Initiated April 11, 2005

    Recall

    Recall Number
    Z-0822-05
    Event Number
    31640
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 11, 2005
    Posted
    May 17, 2005
    Terminated
    January 24, 2007
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035-6301

    Description

    LifeScan brand OneTouch FastTake Blood Glucose Meter

    Reason

    User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia.

    Action

    On 4/11/05, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected products and providing instructions on the correction. Owner's booklet: Firm contacted all accounts by letters of 11/21/03, 2/4/2004, 2/17/04 and 2/9-10/2004 providing important information regarding the owner's booklet.

    Distribution

    Distribution of the product is worldwide. ***Distribution in the United States was between January 15, 2001 for OneTouch Ultra Blood Glucose Meter; April 13, 1998 for OneTouch FastTake Blood Glucose Meter and November 30, 2001 for InDuo Blood Glucose Meter.*** The total number of quantities shipped to consignees is approx. 1.8 Million. Of these, Approx. 282,000 were shipped to Pharmacies and Healthcare Professionals (including Diabetes Educators, Primary Care Physicians, Endocrinologists), Approx. 800 were shipped to Mail Order companies that distribute OneTouch ¿ FastTake¿ and OneTouch ¿ Ultra¿ products, and Approx. 130,000 were shipped to E-mail End User Notifications to LifeScan database of OneTouch¿ Ultra¿, OneTouch¿ FastTake¿ and InDuo¿ product users. Ultra, InDuo, FastTake Meters Global Distribution include: Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Caribbean, CEE, Chile, China, Columbia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latin America, Latin America, Lebanon, Malaysia, Malta, MEA, Mexico, Netherlands, Norway, Oman, Pasean, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia/Gulf Countries, Singapore, Slovakia, Slovenia, South Africa, Spain, Sub-Saharan Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam, and Yemen. Owner's booklet: The recall product was distributed in the U.S. only. LifeScan manufactured and distributed OneTouch Ultra System Kits with the affected OneTouch Ultra Meter Owner's Booklets between March 31, 2003 and October 3, 2003.