BEUDAMED
    FDA Enforcement Class II Terminated

    Vaginal Verification Panel Ref 8208 Lot 8208-11

    Recall: Z-1096-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-1096-2020
    Event ID
    84634
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Microbiologics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    January 3, 2020
    Classification Date
    February 5, 2020
    Termination Date
    September 16, 2020
    Address
    200 Cooper Ave N, N/A, Saint Cloud, MN, 56303-4440, United States

    Description

    Vaginal Verification Panel Ref 8208 Lot 8208-11

    Reason

    Product 8208 Vaginal Verification Panel is a 6 pool kit and has contaminant Candida krusei in Pool 2 (subcomponent 6063). Candida krusei is an organism intended to be contained in Pool 6 of the kit. This should have no impact on patient test results as long as Gardnerella vaginalis was properly detected when using Pool 2 and/or users are strictly using this product for instrument verification/validation.

    Code Info

    Lot 8208-11

    Distribution

    Distributed in the US to 7 states: CA, KS, ME, NC, NY, OR, and UT. No Canada, Mexico or VA.

    Quantity

    9