BEUDAMED
    FDA Recall Terminated

    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests

    Recall: Z-2409-2021 · Initiated July 27, 2021

    Recall

    Recall Number
    Z-2409-2021
    Event Number
    88429
    Firm
    Versea Diagnostics LLC
    FEI Number
    3019891938
    Product Code
    QKO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 27, 2021
    Terminated
    April 10, 2024
    Address
    1000 N Florida Ave, Tampa, FL, 33602-3808

    Description

    Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+- heparin, K2-EDTA and sodium-citrate), and serum. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories. Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests

    Reason

    Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.

    Action

    Versea Diagnostics, LLC began distributing their "URGENT MEDICAL DEVICE RECALL" notices dated 7/14/2021 to their direct consignee on 7/27/2021 by email. The notices instructed the customers immediately discontinue use of these test and quarantine, discard, return, or destroy any unused tests. Confirm any results from these tests using a different EUA authorized test. Discontinue the use of these products if you do not hold the required CLLIA status. Acknowledge your receipt of this notice by completing the attached Response Form, scanning and emailing the completed form to: [email protected]. VERSA Diagnostics, LLC will work with its Customers to either: Affirm their customers authorization to use these products through their CLIA Number and Status Coordinate the return of unused, unopened products to VERSA Diagnostics, LLC The distributors were directed to notify their customers. The firm is seeking return of unused products. If you have questions, please call 800-397-0670 or email us at [email protected]. We are available Monday through Friday from 8:00 AM to 4:00 PM Eastern Time.

    Distribution

    US Nationwide Distribution: AL, AZ, CA, CO, CT, FL, GA, IL, KS, OH, OK, MA, MD, MI, NC, NJ, NY, PA, SC, TX, VA, and WA.

    Quantity

    563,290 in total