BEUDAMED
    FDA Recall Terminated

    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB

    Recall: Z-2876-2020 · Initiated July 13, 2020

    Recall

    Recall Number
    Z-2876-2020
    Event Number
    86122
    Firm
    OraSure Technologies, Inc.
    FEI Number
    3004142665
    Product Code
    JXM
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 13, 2020
    Terminated
    June 8, 2021
    Address
    220 E 1st St, Bethlehem, PA, 18015-1360

    Description

    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB

    Reason

    Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box

    Action

    OraSure Technologies issued Advisory Letter dated July 17,2020 via email stating reason for letter and action to take: While this kit expired at the end of March, 2020; we wanted to take this opportunity to send an updated Specification Sheet with the lot number of the Oral Fluid Negative Calibrator corrected for your files. If you have any questions regarding this issue please contact ourTechnical Services Department at [email protected] and they can assist you .

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.

    Quantity

    39 kits