BEUDAMED
    FDA Recall Open, Classified

    DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.

    Recall: Z-2274-2025 · Initiated June 25, 2025

    Recall

    Recall Number
    Z-2274-2025
    Event Number
    97228
    Firm
    Nuclein LLC
    FEI Number
    3014515702
    Product Code
    QOF
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    June 25, 2025
    Posted
    August 6, 2025
    Address
    8305 Cross Park Dr, Austin, TX, 78754-5154

    Description

    DASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006 combination COVID-19 and Flu test. Each DASH SARS-CoV-2 & Flu A/B Test is individually pouched and labeled. The tests are provided to users in quantities of 10 per kit. Used on the DASH instrument.

    Reason

    Due to manufacturing error, assay test may result in missed diagnosis or delay of treatment. (Potential false negative result)

    Action

    On June 25, 2025, Nuclein, LLC issued a Urgent: Medical Device Recall notification to affected customers. On July 8, 2025 an updated notification was issued via E.Mail. a. Review your inventory of DASH SARS-CoV-2 & Flu A/B Tests to confirm the quantity of Lot BB02 or BB03 that you have remaining. b. Suspend the use and quarantine the affected lot of DASH SARS-CoV-2 & Flu A/B Tests; Nuclein will replace any unused affected product. c. Review all results of the product lots detailed in Section 6, below, to identify potentially erroneous diagnosis, except in those cases where alternative confirmation was obtained. d. Forward this information to all individuals and departments within your organization using the product information detailed in Section 6. If you are not the end user, forward this notice to the product end user. e. Complete the Acknowledgement and Receipt Form below and either email the completed form to [email protected] or mail to the address identified in the Acknowledgement and Receipt Form. f. Return the affected tests that you have remaining; Nuclein Customer Support will follow up with you on the details of returning or destroying the affected product.

    Distribution

    US distribution to: Florida, New York, Texas, and West Virginia

    Quantity

    710 units