BEUDAMED
    FDA Enforcement Class II Terminated

    PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood

    Recall: Z-1403-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1403-2013
    Event ID
    65067
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Polymer Technology Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2013
    Initiation Date
    April 4, 2013
    Classification Date
    May 24, 2013
    Termination Date
    April 16, 2014
    Address
    7736 Zionsville Rd, N/A, Indianapolis, IN, 46268-2175, United States

    Description

    PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood

    Reason

    Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.

    Code Info

    U1117

    Distribution

    Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ.

    Quantity

    7048 total, 3499 in USA