BEUDAMED
    FDA Recall Terminated

    epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system

    Recall: Z-2034-2012 · Initiated June 28, 2011

    Recall

    Recall Number
    Z-2034-2012
    Event Number
    61147
    Firm
    Epocal Inc
    FEI Number
    3004959793
    Product Code
    CGA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 28, 2011
    Posted
    July 19, 2012
    Terminated
    December 18, 2013
    Address
    2060 Walkley Rd, Ottawa Canada Ontario

    Description

    epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM Test Cards are used with the epoc(R) Blood Analysis System which is a POC testing system

    Reason

    Customer reported problem while performing incoming QC of newly received lot of test cards. Liquid quality control results were found to be out of range. Further investigation by Epocal determined that a portion of the test card lot (approximately 3000 cards) could potentially report low glucose results.

    Action

    Epocal Inc. sent a Voluntary Product Recall letter dated June 27, 2011 to the affected consignee. The letter identified the affected products, problem and actions to be taken. The letter ask that all products affected by this recall be sent back to Epocal and a replacement may be obtained. For questions call 1-613-738-6912.

    Distribution

    US nationwide Distribution in the state of CA.

    Quantity

    8,650