BEUDAMED
    FDA Enforcement Class III Terminated

    OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France

    Recall: Z-0793-2013 · Reported February 13, 2013

    Enforcement

    Recall Number
    Z-0793-2013
    Event ID
    64132
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hitachi Chemical Diagnostics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 13, 2013
    Initiation Date
    December 21, 2012
    Classification Date
    February 7, 2013
    Termination Date
    May 16, 2013
    Address
    630 Clyde Ct, N/A, Mountain View, CA, 94043-2239, United States

    Description

    OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France

    Reason

    There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results.

    Code Info

    Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013.

    Distribution

    Worldwide Distribution - France only

    Quantity

    20 kits