BEUDAMED
    FDA Recall Open, Classified

    Matrix Clinical Solution At-Home COVID-19 Test

    Recall: Z-0947-2022 · Initiated January 24, 2022

    Recall

    Recall Number
    Z-0947-2022
    Event Number
    89511
    Firm
    Matrix Medical Network
    FEI Number
    3021556946
    Product Code
    QLW
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    January 24, 2022
    Address
    9201 E Mountain View Rd, Scottsdale, AZ, 85258-5199

    Description

    Matrix Clinical Solution At-Home COVID-19 Test

    Reason

    Due to COVID-19 Test not being authorized for home sample collection.

    Action

    On 01/24/2022 and 03/16/2022, the firm contacted its customers via telephone to informing them that the recall, removal of unused test kits, is being initiated because it appears that sample collection was being conduct from a home setting. FDA has not authorized this test for at-home sample collection. On 03/18/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via US Postal to customer. Customers are being instructed to: 1. Immediately discard the product. 2. If product was used, it is recommended that the user of the product talk to their health care provider if there is any concern about their test results. 3. If the product was further distributed to another person, please notify them of this recall and share the recall letter with them 4. Complete and return the enclosed response form to the below address as soon as possible: - If returning it by email: [email protected] - If returning it by mail: Matrix Clinical Labs, 8161 Maple Lawn Blvd., Ste. 375 Fulton, MD 20759 For questions, call us at 1-855-362-5221. We are available Monday-Friday 8am-4pm EST.

    Distribution

    U.S.: AL, AZ, CA, CO, CT, DC, DE, FL, GA, LA, MA, MD, MI, MN, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, and WV. O.U.S.: N/A

    Quantity

    3,226 kits