BEUDAMED
    FDA Recall Terminated

    Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000

    Recall: Z-1419-2018 · Initiated December 20, 2017

    Recall

    Recall Number
    Z-1419-2018
    Event Number
    79534
    Firm
    OraSure Technologies, Inc.
    FEI Number
    2528909
    Product Code
    DIO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 20, 2017
    Terminated
    April 2, 2020
    Address
    1745 Eaton Ave, Bethlehem, PA, 18018-1769

    Description

    Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000

    Reason

    The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.

    Action

    The email to the firm's consignees states the controls will be replaced.

    Distribution

    Distributed to 2 consignees in KS.

    Quantity

    10