BEUDAMED
    FDA Enforcement Class II Ongoing

    Ringed DxI Reaction Vessels (RVs)

    Recall: Z-2237-2023 · Reported August 2, 2023

    Enforcement

    Recall Number
    Z-2237-2023
    Event ID
    92576
    Classification
    Class II
    Status
    Ongoing
    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
    August 2, 2023
    Initiation Date
    June 20, 2023
    Classification Date
    July 26, 2023
    Address
    1000 Lake Hazeltine Dr, N/A, Chaska, MN, 55318-1037, United States

    Description

    Ringed DxI Reaction Vessels (RVs)

    Reason

    Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service test to evaluate washing efficiency. Increased relative light units (RLU) suspected to be caused by the resulting rough interior surface may lead to artificially falsely elevated results for susceptible tests, in particular, sandwich assays including, but not limited to, hsTnI, Hybritech p2PSA, IPTH/IPTH IO.

    Code Info

    UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, MA, TX, NJ, MI, GA, NC, FL, WV and the country of Qatar.

    Quantity

    213 cases of 10,000 RVs (2,130,000 RVs)