BEUDAMED
    FDA Enforcement Class II Terminated

    Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

    Recall: Z-0030-2014 · Reported October 30, 2013

    Enforcement

    Recall Number
    Z-0030-2014
    Event ID
    66310
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Perkin Elmer Health Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 30, 2013
    Initiation Date
    September 5, 2013
    Classification Date
    October 18, 2013
    Termination Date
    July 17, 2014
    Address
    17 P & N Drive, N/A, Greenville, SC, 29611, United States

    Description

    Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

    Reason

    Some devices may be contaminated on the back side of the device with glue in the blood application area.

    Code Info

    Job number: 313119, Item Lot number: Ohio HEA 2518, Serial numbers: 06132903 - 06198900.

    Distribution

    US distribution in OH

    Quantity

    65,984 devices