BEUDAMED
    FDA Enforcement Class III Terminated

    PerkinElmer 226 Sample Collection Device

    Recall: Z-2264-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2264-2020
    Event ID
    85630
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    PerkinElmer Health Sciences, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 10, 2020
    Initiation Date
    December 19, 2017
    Classification Date
    June 4, 2020
    Termination Date
    March 26, 2021
    Address
    17 P & N Drive, N/A, Greenville, SC, 29611, United States

    Description

    PerkinElmer 226 Sample Collection Device

    Reason

    PerkinElmer 226 Sample Collection Devices Lot Number 40020001 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

    UDI: (01)50812589020011(17)200831(10)40020001; Serial Numbers: 06879601-06879700

    Distribution

    US distribution in the state of Ohio

    Quantity

    164,952 devices