BEUDAMED
    FDA Recall Terminated

    SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not store strips outside vial. Discard 3 months after opening. Distributed by CHdiagnostics, Plymouth, MN 55447, USA. Made in U.K.

    Recall: Z-1546-05 · Initiated March 14, 2005

    Recall

    Recall Number
    Z-1546-05
    Event Number
    32883
    FEI Number
    3004595308
    Product Code
    LFR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 14, 2005
    Posted
    September 15, 2005
    Terminated
    January 23, 2007
    Address
    CHdiagnostics 1 Carlson Pkwy N, Plymouth, MN, 55447-4440

    Description

    SeNova Test Strips for Testing Glucose in Whole Blood. Blood glucose test strips for use with the Senova brand meter only. For in vitro diagnostics use. Do not store strips outside vial. Discard 3 months after opening. Distributed by CHdiagnostics, Plymouth, MN 55447, USA. Made in U.K.

    Reason

    A suspect material used in the manufacturer of the product has degraded over time and consequently may cause falsely high readings when testing your blood glucose level.

    Action

    Sales Representatives will visit their distribution accounts to ensure affected product is removed. Distributors are asked to follow up with their accounts to ensure that no product is left with their customers. Nursing home customers will be mailed letters detailing the recall and not to use the affected lots.

    Distribution

    AL, FL, IA, IL, IN, KS, MD, MN, MO, MS, ND, NY, OH, PA, SD, TN and WI. Distribution to Greece, Czech Republic and Sinapore is typically done through Cambridge Sensors Limited, United Kingdom.

    Quantity

    43,138 vials