BEUDAMED
    FDA Enforcement Class III Terminated

    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT

    Recall: Z-2877-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2877-2020
    Event ID
    86122
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    OraSure Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 2, 2020
    Initiation Date
    July 13, 2020
    Classification Date
    August 24, 2020
    Termination Date
    June 8, 2021
    Address
    220 E 1st St, N/A, Bethlehem, PA, 18015-1360, United States

    Description

    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT

    Reason

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

    Code Info

    Lot Number: 6673116 Exp. Date:03/31/2020

    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

    13 kits