BEUDAMED
    FDA Enforcement Class II Ongoing

    VITROS XT Chemistry Products TBIL-ALKP Slides

    Recall: Z-2623-2023 · Reported September 27, 2023

    Enforcement

    Recall Number
    Z-2623-2023
    Event ID
    92928
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics, INc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 27, 2023
    Initiation Date
    August 5, 2023
    Classification Date
    September 21, 2023
    Address
    513 Technology Blvd, Rochester, NY, 14626-3601, United States

    Description

    VITROS XT Chemistry Products TBIL-ALKP Slides

    Reason

    Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.

    Code Info

    Product Code: 6844296 UDI: (10758750031801) GEN #16; Expiry Date Range 01 Jul 2023 - 01 Sep 2023 GEN #17; Expiry Date Range 01 Nov 2023 - 01 Feb 2024 GEN #18; Expiry Date Range 01 Apr 2024 - 01 Aug 2024 GEN #19; Expiry Date Range 01 Aug 2024 - 01 Jan 2025

    Distribution

    Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to countries of: Bermuda, Belgium, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Italy, India, Japan, Mexico, Netherlands, Norway, Singapore, Spain, Sweden, Portugal, Russia, United Kingdom

    Quantity

    52,456 units