BEUDAMED
    FDA Recall 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 · Initiated April 4, 2013

    Recall

    Recall Number
    Z-1403-2013
    Event Number
    65067
    Firm
    Polymer Technology Systems, Inc.
    FEI Number
    3015525148
    Product Code
    NBW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    April 4, 2013
    Posted
    May 25, 2013
    Terminated
    April 16, 2014
    Address
    7736 Zionsville Rd, Indianapolis, IN, 46268-2175

    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.

    Action

    Polymer Technology Systems sent a Field Correction Action letters dated April 4, 2013 to distributors and customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use and dispose of remaining inventory of recalled product. Customers were asked to acknowledge and confirm recall directions were follwed by fax to 1-317-870-5608.

    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