BEUDAMED
    FDA Enforcement Class II Terminated

    BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.

    Recall: Z-3006-2020 · Reported September 30, 2020

    Enforcement

    Recall Number
    Z-3006-2020
    Event ID
    86386
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Beckman Coulter Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 30, 2020
    Initiation Date
    August 26, 2020
    Classification Date
    September 24, 2020
    Termination Date
    May 24, 2024
    Address
    250 S Kraemer Blvd, N/A, Brea, CA, 92821-6232, United States

    Description

    BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.

    Reason

    Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.

    Code Info

    Catalog Number: 33570 UDI Code: (01)15099590231187 Serial/Lot Numbers: 921133 921348 921742

    Distribution

    Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, WA, WI and Puerto Rico. The countries of Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Czech Republic, Germany, Hungary, India, Ireland, Italy, Jordan, Lebanon, Malaysia, Mexico, Nepal, Pakistan, Panama, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

    Quantity

    21455 assay systems