BEUDAMED
    FDA Recall Terminated

    Vaginal Verification Panel Ref 8208 Lot 8208-11

    Recall: Z-1096-2020 · Initiated January 3, 2020

    Recall

    Recall Number
    Z-1096-2020
    Event Number
    84634
    Firm
    Microbiologics Inc
    FEI Number
    2150138
    Product Code
    OHQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 3, 2020
    Terminated
    September 16, 2020
    Address
    200 Cooper Ave N, Saint Cloud, MN, 56303-4440

    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.

    Action

    Letters will be sent via email to all consignees and end users regarding the correction. Users are to review the instructions, determine how the information affects their usage, and upon determination either use with new information or discard the product.

    Distribution

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

    Quantity

    9