BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1183-2021 · Initiated February 5, 2021

    Recall

    Recall Number
    Z-1183-2021
    Event Number
    87340
    Firm
    OraSure Technologies, Inc.
    FEI Number
    3004142665
    Product Code
    LAF
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 5, 2021
    Terminated
    March 30, 2023
    Address
    220 E 1st St, Bethlehem, PA, 18015-1360

    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.

    Action

    Orasure issued Advisory Letters issued on 2/05/21 via Certified Mail receipt. Letter states reason for recall, health risk and action to take: OraSure Technologies, Inc. has generated a new Specification Sheet for the Methamphetamine Kit with the alternate Substrate Reagent Lot 6679623 included with this advisory letter. Retain testing done using the alternate Substrate Reagent revealed no impact to the kit's performance. If you have any questions regarding this issue please contact out Technical Services Department at technicalserviceQcorasure.coin and they can assist you

    Distribution

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

    Quantity

    16 units