BEUDAMED
    FDA Recall 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 · Initiated October 20, 2021

    Recall

    Recall Number
    Z-0452-2022
    Event Number
    89064
    Firm
    Biomeme, Inc.
    FEI Number
    3014117298
    Product Code
    QJR
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    October 20, 2021
    Terminated
    March 5, 2024
    Address
    1015 Chestnut St, Philadelphia, PA, 19107-4316

    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).

    Action

    On October 20, 2021, the firm sent an informal notice to customers titled "Product Update: Storing your RNA Process Control (RPC)". On November 4, 2021, the firm followed up with a formal notice titled "Medical Device Correction". The letter notified customers of the need to shorten the life of the RPC Buffer once resuspended from one week to TWO DAYS while stored at room temperature (15 degrees Celsius - 30 degrees Celsius). Actions to be taken by the Customer: Effective immediately, users of resuspended RPC Buffer should discard after two days when stored at room temperature. For longer-term storage, the RPC Buffer can be frozen once, at a temperature of -20C, for up to 3 months, and should not be frozen and thawed more than once. The expiration date of unopened RPC Kits will remain the same. Customers were also instructed to confirm receipt of the notification through a link provided by the firm. Customers should discard any other documents they may have on-hand that specifies the longer shelf-life stated in the IFU. When available, Biomeme will deliver updated versions of the IFU to all users by email.

    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