BEUDAMED
    FDA Enforcement Class III Terminated

    Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.

    Recall: Z-1183-2021 · Reported March 17, 2021

    Enforcement

    Recall Number
    Z-1183-2021
    Event ID
    87340
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    OraSure Technologies, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 17, 2021
    Initiation Date
    February 5, 2021
    Classification Date
    March 5, 2021
    Termination Date
    March 30, 2023
    Address
    220 E 1st St, Bethlehem, PA, 18015-1360, United States

    Description

    Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.

    Reason

    Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.

    Code Info

    Lot 6681090, Exp date 2021-03. UDI: 608337000191

    Distribution

    US Nationwide distribution in the states of KS, NJ, OH, VA.

    Quantity

    16 units