BEUDAMED
    FDA Enforcement Class II Ongoing

    VITROS Performance Verifier II

    Recall: Z-1373-2024 · Reported April 3, 2024

    Enforcement

    Recall Number
    Z-1373-2024
    Event ID
    94174
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 3, 2024
    Initiation Date
    February 27, 2024
    Classification Date
    March 22, 2024
    Address
    1000 Lee Rd, N/A, Rochester, NY, 14606-4250, United States

    Description

    VITROS Performance Verifier II

    Reason

    The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.

    Code Info

    Product Code: 8231474; GTIN: 10758750004577; Lot No. R1176.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.

    Quantity

    11,224 units