BEUDAMED
    FDA Recall Terminated

    PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample

    Recall: Z-1903-2012 · Initiated May 15, 2012

    Recall

    Recall Number
    Z-1903-2012
    Event Number
    61966
    Firm
    Polymer Technology Systems, Inc.
    FEI Number
    3015525148
    Product Code
    JFY
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 15, 2012
    Posted
    June 28, 2012
    Terminated
    July 20, 2012
    Address
    7736 Zionsville Rd, Indianapolis, IN, 46268-2175

    Description

    PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample

    Reason

    During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay.

    Action

    Polymer Technology Systems, Inc sent a URGENT FIELD CORRECTION letter dated May 15, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customers to discontinue use and dispose of the product. PTS Inc. will provide appropriate replacement for any product that is properly identified on the attached Customer Acknowledgement and confirmation letter, If you have any questions please contact Customer Service toll-free at 1-877-870-5610, or +1-317-870-5610 ( outside the US )

    Distribution

    Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.

    Quantity

    1650 vials