BEUDAMED
    FDA Recall Terminated

    arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.

    Recall: Z-0630-2016 · Initiated December 18, 2015

    Recall

    Recall Number
    Z-0630-2016
    Event Number
    72860
    Firm
    Arkray Factory USA, Inc.
    FEI Number
    1832816
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    December 18, 2015
    Posted
    January 15, 2016
    Terminated
    January 4, 2017
    Address
    5182 W 76th St, Minneapolis, MN, 55439-2900

    Description

    arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.

    Reason

    One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip are being recalled due to a lowered reaction rate in the reagent pad for glucose. The affected lots will display a result of approximately 300 to 400 mg/dL for any glucose value that exceeds the upper limit of 416 mg/dL.

    Action

    The firm sent an Urgent Medical Device Recall letter to customers beginning 12/18/2015. The letter identified affected product, stated the reason for recall and asked for unused product to be returned. For instructions on returning unused product contact Lesty Jaranilla 1-877-538-8872 x3243.

    Distribution

    Distributed in the states of FL, IL, KY, MI, NC, NY, OH, and TN.

    Quantity

    88 boxes (25 foil packaged test strips per box)