BEUDAMED
    FDA Enforcement Class III Terminated

    PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.

    Recall: Z-2756-2017 · Reported August 2, 2017

    Enforcement

    Recall Number
    Z-2756-2017
    Event ID
    77668
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer Health Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 2, 2017
    Initiation Date
    May 31, 2017
    Classification Date
    July 24, 2017
    Termination Date
    July 27, 2017
    Address
    17 P & N Drive, N/A, Greenville, SC, 29611, United States

    Description

    PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory in Newborn Screening.

    Reason

    PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial numbers printed on the pack labels that did not match the serial number range of the devices contained within the pack.

    Code Info

    lot numbers 317113 and 317114

    Distribution

    US Distribution to the state of : AL

    Quantity

    99,968 units