BEUDAMED
    FDA Enforcement Class I Ongoing

    SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT

    Recall: Z-1401-2022 · Reported August 10, 2022

    Enforcement

    Recall Number
    Z-1401-2022
    Event ID
    90381
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    North American Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 10, 2022
    Initiation Date
    June 15, 2022
    Classification Date
    July 29, 2022
    Address
    618 Ridgewood Ave, N/A, Holly Hill, FL, 32117-3604, United States

    Description

    SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT

    Reason

    Various brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing approval, clearance, or authorization from FDA.

    Code Info

    Lot: FLUSA 1020-1, Batches 8, 10, and 12

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, LA, NV, CA, CO, AZ, CT, OH. IL, NY, DC, MD, PA, and the countries of Zambia, Austria, Canada, UAE, Bangladesh.

    Quantity

    122,366 units