BEUDAMED
    FDA Recall 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 · Initiated May 31, 2017

    Recall

    Recall Number
    Z-2756-2017
    Event Number
    77668
    Firm
    PerkinElmer Health Sciences, Inc.
    FEI Number
    3007145015
    Product Code
    PJC
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    May 31, 2017
    Posted
    July 24, 2017
    Terminated
    July 27, 2017
    Address
    17 P & N Drive, Greenville, SC, 29611

    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.

    Action

    PerkinElmer sent an Urgent Medical Device Correction letter dated May 30, 2017, to the sole consignee. PerkinElmer requested the consignee implement the following actions: 1. Discontinue use of the pack label to track the device serial numbers distributed to your sample submitters. 2. Verify submitter of devices received without provider information prior to demographic entry. 3. Verify the serial number of the pack label matches the device serial numbers within the pack of your undistributed inventory prior to distributing to your sample submitter or, 4. Return undistributed inventory to PerkinElmer for inspection , and rework if required. For further questions please call (864) 299-8787.

    Distribution

    US Distribution to the state of : AL

    Quantity

    99,968 units