BEUDAMED
    FDA Recall Terminated

    11 Panel Card (OPI 300) w/Adult, Item No. 71125AA

    Recall: Z-0487-2016 · Initiated November 16, 2015

    Recall

    Recall Number
    Z-0487-2016
    Event Number
    72651
    Firm
    Ameditech Inc
    FEI Number
    3003789989
    Product Code
    JXM
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 16, 2015
    Terminated
    November 9, 2016
    Address
    9940 Mesa Rim Rd, San Diego, CA, 92121-2910

    Description

    11 Panel Card (OPI 300) w/Adult, Item No. 71125AA

    Reason

    Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide.

    Action

    A Medical Device Labeling Correction letter was sent on 11/16/15 to distributors and end users to inform them that Ameditechs Drugs of Abuse Tests have shown reduced reactivity for up to two (2) of the nineteen (19) BZO compounds for which specificity information is provided in the product insert. The letter informs the customers that the particular BZO compounds for which there may be reduced reactivity are Clonazepam and Chlordiazepoxide. Customers with questions are instructed to contact Ameditech at (844) 616-4453 or email at [email protected].

    Distribution

    Nationwide Distribution.

    Quantity

    50 kits