BEUDAMED
    FDA Recall Terminated

    Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.

    Recall: Z-0124-2021 · Initiated September 17, 2020

    Recall

    Recall Number
    Z-0124-2021
    Event Number
    86276
    Firm
    Quidel Corporation
    FEI Number
    2024674
    Product Code
    QKP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 17, 2020
    Terminated
    August 9, 2022
    Address
    10165 McKellar Ct, San Diego, CA, 92121-4201

    Description

    Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms.

    Reason

    Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all references to a specific viral transport medium product as well as the use of other viral transport media. Use of the specific viral transport medium products may result in False-positive results. Directly testing from specimens (NS or NP swab) is recommended.

    Action

    On 09/17/20, "FIELD CORRECTIVE ACTION CORRECTION" notices dated 09/16/20 were emailed to customers. The firm called customers over the phone to convey the correction information to some customers. Customers were asked to take the following actions: 1) Discontinue the use of affected package inserts. 2) Access the updated instructions for use labeling which can be located by going to quidel.com/docs and selecting the Sofia SARS Antigen FIA Package Insert document. 3) In the event that your facility has used Remel viral transport media products (e.g., M4, M4RT, M6), please contact Quidel Technical Support to discuss your results. 4) Confirm receipt of this notice by returning a signed copy to [email protected] Please feel free to contact Technical Support at [email protected] or by calling 800.874.1517 (in the U.S.) with any questions or concerns that you may have regarding this issue.

    Distribution

    U.S. Nationwide Distribution: NY, KS, TX, AL, FL, MN, CA, IL, MA, MS, PA, GA, NH, MO, VA, MI, OR, WV, OK, NV, CT, TN, MD, LA, AR, HI, NJ, KY, VT, IA, RI, NM, OH, IN, AK, SC, NC, AZ, SD, NE, WI, and.CO.

    Quantity

    10537