BEUDAMED
    FDA Enforcement Class II Terminated

    iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300) 5 Adulteration Tests: Cr, Ni, pH, Bl, S.G.", X11-I-DX-1147-022 /"iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300)"

    Recall: Z-3040-2020 · Reported October 7, 2020

    Enforcement

    Recall Number
    Z-3040-2020
    Event ID
    86335
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ameditech Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 7, 2020
    Initiation Date
    August 18, 2020
    Classification Date
    September 30, 2020
    Termination Date
    September 30, 2024
    Address
    9940 Mesa Rim Rd, N/A, San Diego, CA, 92121-2910, United States

    Description

    iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300) 5 Adulteration Tests: Cr, Ni, pH, Bl, S.G.", X11-I-DX-1147-022 /"iCup" Dx 14 Drug Screen Cup 14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+ (BAR300/MTD300)+(BUPG10/TCA1000)+(MDMA500/OXY100)+(PCP25/PPX300)"

    Reason

    Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.

    Code Info

    ALL Lots Within Expiry

    Distribution

    US - Nationwide OUS - Australia, France, Germany, New Zealand, Singapore and Spain

    Quantity

    136,925 units