BEUDAMED
    FDA Enforcement Class III Terminated

    QuickTox 5 Panel Drug Screen DipCard

    Recall: Z-0692-2020 · Reported December 25, 2019

    Enforcement

    Recall Number
    Z-0692-2020
    Event ID
    84239
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ameditech Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 25, 2019
    Initiation Date
    February 15, 2019
    Classification Date
    December 17, 2019
    Termination Date
    April 28, 2021
    Address
    9940 Mesa Rim Rd, San Diego, CA, 92121-2910, United States

    Description

    QuickTox 5 Panel Drug Screen DipCard

    Reason

    Mixed Products containing QuickTox 5 Panel Drugs Screen Dipcard (P/N QT11, LOT #188787) and Alere iScreen Drugs of Abuse Dip Test (P/N X11-IS10-22015-DX LOT #188744)

    Code Info

    Catalog Number: QT11 Lot Number: 188787

    Distribution

    US - AZ, CA, FL, GA, KS, LA, MI, MO, MS, NC, OK, TN, and TX. OUS - None

    Quantity

    3400 units (136 kits)