BEUDAMED
    FDA Enforcement Class II Ongoing

    VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)

    Recall: Z-0236-2024 · Reported November 15, 2023

    Enforcement

    Recall Number
    Z-0236-2024
    Event ID
    93238
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ortho-Clinical Diagnostics, INc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 15, 2023
    Initiation Date
    September 12, 2023
    Classification Date
    November 6, 2023
    Address
    513 Technology Blvd, Rochester, NY, 14626-3601, United States

    Description

    VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)

    Reason

    Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsely low levels could result in a missed or delayed diagnosis of acute pancreatitis and may lead to diagnostic confusion in the setting of acute abdominal symptoms. Falsely elevated levels would not result in patient harm but may cause diagnostic confusion and a delay in accurate diagnosis of a patient with abdominal pain.

    Code Info

    Product Code 1668409: UDI-DI: 10758750009510, Affected Lots: 5905-3348-1557; Product Code 8297749: UDI-DI: 10758750004683, Affected Lots: 5905-3348-2899

    Distribution

    US States: CA, CO, FL, GA, IL, IN, KS, NC, NY, TN, TX, VT. Canada, France, India, Japan, South Korea

    Quantity

    342 units