BEUDAMED
    FDA Recall Terminated

    DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.

    Recall: Z-1033-2015 · Initiated November 21, 2014

    Recall

    Recall Number
    Z-1033-2015
    Event Number
    70008
    Firm
    Express Diagnostics Int'l., Inc.
    FEI Number
    3014946040
    Product Code
    MGX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 21, 2014
    Posted
    January 30, 2015
    Terminated
    May 14, 2019
    Address
    1550 Industrial Dr, Blue Earth, MN, 56013-1100

    Description

    DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 30108C, 30108C CAN, 30108C EU, and 30108C INT. This assay provides only a preliminary analytical test result.

    Reason

    This recall has been initiated due to potential false positives results when using the test to screen for Ketamine. Use of this product may give incorrect screening results.

    Action

    Consignees were sent an Express Diagnostic Int. Inc., "Urgent" Letter dated 11//21/2014. The letter described the problem and the product involved in the recall. It advised consignees to quarantine the product. If the product has been further distributed, consignees were advised to notify their customers at once, Consignees were requested to complete and return the "Acknowledgement Form" either via fax to 1-507-526-2252 or e-mail [email protected]. For questions consignees can contact Jackie Gale, Director of Quality Systems and Regulatory Affairs at 1-507-526-3951.

    Distribution

    Worldwide Distribution -- US, including the states of CA, NY, MN, and SC; SWEDEN, CANADA, UNITED KINGDOM, and GUATEMALA.

    Quantity

    5,050