BEUDAMED
    FDA Enforcement Class II 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 · Reported February 11, 2015

    Enforcement

    Recall Number
    Z-1033-2015
    Event ID
    70008
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Express Diagnostics Int'l., Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2015
    Initiation Date
    November 21, 2014
    Classification Date
    January 30, 2015
    Termination Date
    May 14, 2019
    Address
    1550 Industrial Dr, N/A, Blue Earth, MN, 56013-1100, United States

    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.

    Code Info

    PC 09077, PC03227, PC03055, PC09293, PC11115, PC08126, PC06276, PC07085, PC06305, and PC08017.

    Distribution

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

    Quantity

    5,050