BEUDAMED
    FDA Recall Terminated

    Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341

    Recall: Z-2508-2021 · Initiated August 5, 2021

    Recall

    Recall Number
    Z-2508-2021
    Event Number
    88612
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    QKO
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    August 5, 2021
    Terminated
    June 1, 2023
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Access SARS CoV-2 IgG (1st IS) Assay: Access Immunoassay Systems REAGENT PACK, REF C74339 Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340 Access SARS-CoV-2 (1st IS) Quality Control (QC), REF C74341

    Reason

    Firm's submission for Emergency Use Authorization (EUA) contained insufficient evidence to be granted EUA Authorization to distribute

    Action

    On 08/06/2021, the firm sent an initial "URGENT MEDICAL DEVICE RECALL" Notification informing its customers that due insufficient evidence the firm was not issued an Emergency Use Authorization for its SARS-CoV-2 IgG (1st IS) assay and required to discontinue distribution and to recall all affected products. On 09/13/2021 the firm sent a revised "URGENT MEDICAL DEVICE RECALL UPDATE" to inform its customers about the potential risks/harms related to using the affected products, such as, the assay may generate discordant results such as false positive, false negative or misinterpreted results when compared to other World Health Organization (WHO) traceable assays. Customers are instructed to: 1. Immediately discontinue using the Access SARS-CoV-2 IgG (1st IS) assay. 2. Discard all Access SARS-CoV-2 (1st IS) reagent packs, calibrators, and quality control. 3. A retrospective review of patient test results obtained with the Access SARS-CoV-2 IgG (1st IS) assay is not required. Any review is left to the discretion of the Laboratory Medical Director. 4. Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. 5. If any of the affected products have been forwarded to another laboratory, provide them with the notification. 6. Complete and return the Customer Response Form within 10 days electronically via email or manually via mail 7. For credit for the affected products, complete the Customer Response Form For questions, contact Customer Support Center via: Website - http://www.beckmancoulter.com Phone - 1-800-854-3633 in the United States

    Distribution

    U.S. Nationwide distribution in the states of AZ, CA, GA, IL, IA, KY, MI, NJ, NY, NC, OH, PA, Puerto Rico, TN, TX, VA, and WA.

    Quantity

    303 kits (U.S.) and 964 kits (O.U.S.)