BEUDAMED
    FDA Enforcement Class II Terminated

    Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564

    Recall: Z-0452-2022 · Reported January 12, 2022

    Enforcement

    Recall Number
    Z-0452-2022
    Event ID
    89064
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomeme, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 12, 2022
    Initiation Date
    October 20, 2021
    Classification Date
    January 4, 2022
    Termination Date
    March 5, 2024
    Address
    1015 Chestnut St, N/A, Philadelphia, PA, 19107-4316, United States

    Description

    Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564

    Reason

    The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stored at room temperature. Ongoing stability studies have indicated the need to shorten the life of the RPC Buffer once resuspended from the current instruction of one week to two days when stored at room temperature (15degC-30degC).

    Code Info

    All lots. Last lot of Kit distributed with the old IFU is 20210914.

    Distribution

    Domestic distribution to AZ, CA, FL, HI, IN, KY, MD, MO, NC, NJ, NY, OH, OK, PA, TX, VA. Foreign distribution to Ghana, Dominican Republic, and Singapore.

    Quantity

    11,607