BEUDAMED
    FDA Recall Terminated

    PerkinElmer 226 Sample Collection Device

    Recall: Z-2264-2020 · Initiated December 19, 2017

    Recall

    Recall Number
    Z-2264-2020
    Event Number
    85630
    Firm
    PerkinElmer Health Sciences, Inc.
    FEI Number
    3007145015
    Product Code
    PJC
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 19, 2017
    Terminated
    March 26, 2021
    Address
    17 P & N Drive, Greenville, SC, 29611

    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.

    Action

    PerkinElmer sent an Urgent Medical Device Correction letter dated 12/22/2017 by email to the sole consignee. PerkinElmer requested the consignee quarantine the product and contact Kerry Chunko, PerkinElmer Sr. Quality Manager for further information 864-299-8787. x 104 ([email protected]). The firm also requested the consignee inform all those affected by this issue in their organization and to return the recall response form and return it by fax to 864-299-8787 or as a scanned by email to [email protected].

    Distribution

    US distribution in the state of Ohio

    Quantity

    164,952 devices