BEUDAMED
    FDA Recall Open, Classified

    Ringed DxI Reaction Vessels (RVs)

    Recall: Z-2237-2023 · Initiated June 20, 2023

    Recall

    Recall Number
    Z-2237-2023
    Event Number
    92576
    Firm
    Beckman Coulter, Inc.
    FEI Number
    2122870
    Product Code
    JJE
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    June 20, 2023
    Posted
    July 26, 2023
    Address
    1000 Lake Hazeltine Dr, Chaska, MN, 55318-1037

    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.

    Action

    A customer letter titled, Urgent Medical Device Recall, dated 06/07/2023, was issued to the impacted consignee via first-class mail and email. The consignee is instructed to discard the product and request a replacement. The consignee is asked to complete the response form and submit to the recalling firm.

    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)