BEUDAMED
    FDA Recall Terminated

    QuickTox 5 Panel Drug Screen DipCard

    Recall: Z-0692-2020 · Initiated February 15, 2019

    Recall

    Recall Number
    Z-0692-2020
    Event Number
    84239
    Firm
    Ameditech Inc
    FEI Number
    3003789989
    Product Code
    DJG
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 15, 2019
    Posted
    December 17, 2019
    Terminated
    April 28, 2021
    Address
    9940 Mesa Rim Rd, San Diego, CA, 92121-2910

    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)

    Action

    On February 15, 2019, the firm sent a "FIELD CORRECTIVE ACTION NOTIFICATTION" via email (read receipt requested), and/or via certified mail with delivery tracking to its customers informing them of mixed products, QuickTox 5 Panel Drugs Screen Dipcard, part number QT11 with lot number 188787 containing Alere iScreen Drugs of Abuse Dip Test, part number X11-IS10-22015-DX lot number 188744. Customer are being requested to return the affected products and if products were further distributed customers are to notify those customers and request for return of affected products. In addition, all customers receiving the notice are asked to complete and return the included "Customer Verification Form" via fax 888-340-4029.

    Distribution

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

    Quantity

    3400 units (136 kits)