BEUDAMED
    FDA Recall Terminated

    arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.

    Recall: Z-0631-2016 · Initiated December 18, 2015

    Recall

    Recall Number
    Z-0631-2016
    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 Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.

    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

    11 boxes (25 foil packaged test strips per box)