BEUDAMED
    FDA Recall Terminated

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    Recall: Z-1543-2018 · Initiated March 14, 2018

    Recall

    Recall Number
    Z-1543-2018
    Event Number
    79778
    Firm
    Polymer Technology Systems, Inc.
    FEI Number
    3015525148
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 14, 2018
    Terminated
    September 13, 2018
    Address
    7736 Zionsville Rd, Indianapolis, IN, 46268-2175

    Description

    PTS Panels CHOL+GLU Test Strips (REF 1765)

    Reason

    Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018)

    Action

    Letters will be sent to each ship-to address, as well as each bill-to address via UPS with signature requirement. Customers will be instructed to immediately quarantine and destroy any materials remaining from these two lots.

    Distribution

    OH, PR, VA, CAL, IL, FL, WA, TN, KY, OH, MN, NY and Belgium, Hong Kong, Sweden, Australia, Russia, Sweden, Brazil, England