BEUDAMED
    FDA Enforcement Class II Terminated

    PTS Panels¿ CHOL+GLU Test Strips (REF 1765)

    Recall: Z-1543-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1543-2018
    Event ID
    79778
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Polymer Technology Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 9, 2018
    Initiation Date
    March 14, 2018
    Classification Date
    April 28, 2018
    Termination Date
    September 13, 2018
    Address
    7736 Zionsville Rd, N/A, Indianapolis, IN, 46268-2175, United States

    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)

    Code Info

    Lot # A705 UDI (01)00381931765016(17)180813(10)A705

    Distribution

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

    Quantity

    N/A