BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated June 15, 2022

    Recall

    Recall Number
    Z-1401-2022
    Event Number
    90381
    Firm
    North American Diagnostics
    FEI Number
    3021477751
    Product Code
    QKP
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    June 15, 2022
    Address
    618 Ridgewood Ave, Holly Hill, FL, 32117-3604

    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.

    Action

    The firm initiated their recall by email on 06/15/2022. The letter explained the issue and requested the consignee take the following actions: "" Immediately destroy all unused product to North American Diagnostics Inc. " Immediately identify all affected product in your inventory and segregate to avoid inadvertent use or further distribution. " Complete the attached response form and return it to Elizabeth Lashinsky [email protected]. " If you have further distributed any of these products, please notify your customers immediately with a copy of this notice, and please request that your customers destroy any product they may have in inventory and confirm in writing that they have done so. " If you have relabeled the product prior to distributing it, please indicate the number below and the name on the label. If you have questions or concerns regarding this recall, or problems with the product, please contact Elizabeth A. Lashinsky, Manager, [email protected], 407-312-7104.

    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