BEUDAMED
    FDA Enforcement Class II Terminated

    Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS.

    Recall: Z-2153-2014 · Reported August 13, 2014

    Enforcement

    Recall Number
    Z-2153-2014
    Event ID
    68686
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer Health Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 13, 2014
    Initiation Date
    July 1, 2014
    Classification Date
    August 6, 2014
    Termination Date
    October 21, 2015
    Address
    940 Winter St, N/A, Waltham, MA, 02451-1457, United States

    Description

    Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS.

    Reason

    Risk of incorrect results from samples prepared with Panthera-Puncher 9

    Code Info

    Serial Numbers: 20810001 through 20810148

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of : Canada, Australia, Brazil, China, Denmark, Great Britain, Italy, France, Mexico, Qatar and Korea.

    Quantity

    144 units