BEUDAMED
    FDA Enforcement Class II Terminated

    ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.

    Recall: Z-0875-2021 · Reported January 27, 2021

    Enforcement

    Recall Number
    Z-0875-2021
    Event ID
    87146
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 27, 2021
    Initiation Date
    December 30, 2020
    Classification Date
    January 15, 2021
    Termination Date
    September 19, 2022
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.

    Reason

    The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.

    Code Info

    Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS,KY, LA, MD, MI, MN, MO, NC, ND, NY, OH, OK, OR, PA, Puerto Rico, SD, TX, WA, and WV. The countries of Andorra, Belgium, Brazil, Bulgaria, Canada*, Croatia, France, Germany, Hong Kong, Italy, Jordan, Mexico, Paraguay, Poland, Portugal, Romania, Spain, and United Kingdom.

    Quantity

    276 units