BEUDAMED
    FDA Recall Terminated

    LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037

    Recall: Z-0887-05 · Initiated November 17, 2003

    Recall

    Recall Number
    Z-0887-05
    Event Number
    32200
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 17, 2003
    Posted
    June 14, 2005
    Terminated
    September 20, 2005
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035-6301

    Description

    LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037

    Reason

    A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.

    Action

    On 11/17/03 the firm initiated the recall and their notification was via letters informing its customers of the removal.

    Distribution

    Product was released for distribution to 30 consignees nationwide. The firm provided the following distribution information: 6 wholesaler dealers, 20 distributors, 3 retailers and one (1) consumers/users involved in the recall. Note: This customer received a shipment of 2 Test Strip boxes (2 boxes x 50 strips/box = 100 test strips) as 'free goods' and was most likely for an LifeScan employee in the field. The lot was released from LifeScan's facility in Puerto Rico on May 1, 2003 and received at LifeScan's warehouse in Milpitas, CA on May 16, 2003. From the Milpitas warehouse, this lot was transferred to LifeScan's warehouse in Mechanicsburg, PA where it was received on June 16, 2003. The affected lot was distributed out of the Mechanicsburg, PA warehouse only. The recall product was distributed in the U.S. only, to the following states: AL, DE, FL, IL, IN, MA, MI, MN, MO, NC, NH, NJ, OH, PA, TN, TX, VA and WV. (A second lot was also mislabeled with the incorrect Control Solution range. This lot was manufactured outside of the US and distributed exclusively in Italy.) The total number of government sales/distribution centers that received the recall product = 0.

    Quantity

    8,718 boxes (containing 435,900 test strips)