BEUDAMED
    FDA Enforcement Class I Terminated

    Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic

    Recall: Z-0738-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0738-2018
    Event ID
    78942
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ventana Medical Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 7, 2018
    Initiation Date
    December 19, 2017
    Classification Date
    September 14, 2018
    Termination Date
    November 22, 2021
    Address
    1910 E Innovation Park Dr, N/A, Oro Valley, AZ, 85755-1962, United States

    Description

    Hematoxylin II, Ventana Part Number 790-22087, Roche GMMI 05277965001 in vitro diagnostic

    Reason

    Increased reports of leaking and sticking reagent dispensers for horseradish peroxidase (HRP) dispensers (part of the iView, ultraView and OptiView detection kits, as well as CINtec PLUS Cytology Kit) and with Hematoxylin II.

    Code Info

    UDI 04015630972135, Lot Numbers: Y10759, Y17402, Y21312, Y13938, Y17403, Y22561

    Distribution

    Worldwide distribution, including US nationwide, Argentina, Australia, Hong Kong, Indonesia, Philippines, Brazil, Chile, Thailand, Korea, Malaysia, New Zealand, Ecuador, Mexico, Pakistan, Vietnam, Germany, Japan, India, Colombia, Singapore, Uruguay, Peru, Canada, Taiwan, China,

    Quantity

    71640 units