BEUDAMED
    FDA Recall Terminated

    OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit; One Touch Verio IQ Blood Glucose Monitoring Warranty Kit. Distributed by : LifeScan, Inc. Milpitas, CA 95035 for: LifeScan Europe Division of Cilag GmBH International 6300 Zug Switzerland Meter made in China. Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood.

    Recall: Z-1359-2012 · Initiated February 21, 2012

    Recall

    Recall Number
    Z-1359-2012
    Event Number
    61272
    Firm
    Lifescan Inc
    FEI Number
    2939301
    Product Code
    LFR
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 21, 2012
    Posted
    April 2, 2012
    Terminated
    February 5, 2013
    Address
    1000 Gibraltar Dr, Milpitas, CA, 95035

    Description

    OneTouch Verio IQ Blood Glucose Monitoring System Kit; One Touch Verio IQ Blood Glucose IQ Blood Glucose Monitoring Starter Kit; One Touch Verio IQ Blood Glucose Monitoring Warranty Kit. Distributed by : LifeScan, Inc. Milpitas, CA 95035 for: LifeScan Europe Division of Cilag GmBH International 6300 Zug Switzerland Meter made in China. Intended to be used for the quantitative measurement of glucose in fresh capillary whole blood.

    Reason

    An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user attempts to view results in the "Results Log" when the log has 256 or a multiple of 256 items to display.

    Action

    Lifescan sent an Urgent Medical Device Voluntary Recall letter dated February 21, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1. Identify and sequester all lots of OneTouch Verio"IQ Meters they have in inventory. UPC No. 353885007702 LifeScan Part No. 022267 NDC No. 53885026701 Note: Only OneTouch Verio"IQ Meters are subject to this notice. Please continue to sell all other OneTouch Brand products including OneTouch Verio" Test Strips and all OneTouch Ultra Brand Meters, Test Strips and Ancillary Products. 2. Communicate this replacement program to their distribution centers and retail stores that have received OneTouch Verio"IQ Meters. Request that they return only OneTouch Verio"IQ Meters per their normal return procedures. 3. Once you received all of the OneTouch Verio"IQ Meters to be returned, call Inmar Corp. at 336-631-7744 for a Returned Goods Authorization (RGA) number and product return instructions. When product has been returned, a credit memo for an amount equivalent to the invoiced price of the returned product. No deductions will be allowed. If you have any questions about this action, please contact your LifeScan Sales Representative or call the LifeScan Customer Experience Line at: 1-800-600-7226, Option 1. Customers were advised that they can continue use of their affected product until an updated meter is provided free of charge. For questions regarding this recall call 408-942-5937.

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada

    Quantity

    101,841 units. 2-27-12 - this figure is an estimate and will be updated when more accurate number is received.