BEUDAMED
    FDA Recall Terminated

    Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.

    Recall: Z-0722-2017 · Initiated November 10, 2016

    Recall

    Recall Number
    Z-0722-2017
    Event Number
    75681
    Firm
    OraSure Technologies, Inc.
    FEI Number
    2528909
    Product Code
    DIS
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    November 10, 2016
    Posted
    December 8, 2016
    Terminated
    April 17, 2017
    Address
    1745 Eaton Ave, Bethlehem, PA, 18018-1769

    Description

    Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.

    Reason

    Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.

    Action

    Due to the small number of customers that were affected by the recall, OraSure notified customers on November 10, 2016, via telephone with a follow-up email. Customers were asked to quarantine the units on hand and they will schedule a pickup by Fed EX to retrieve the affected units. For further questions, please call (610) 882-1820, ext. 1657

    Distribution

    Distributed to KS, and VA

    Quantity

    4 kits