BEUDAMED
    FDA Recall Terminated

    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.

    Recall: Z-2166-2014 · Initiated June 27, 2014

    Recall

    Recall Number
    Z-2166-2014
    Event Number
    68670
    Firm
    PerkinElmer Health Sciences, Inc.
    FEI Number
    3006159931
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 27, 2014
    Posted
    August 7, 2014
    Terminated
    April 6, 2015
    Address
    940 Winter St, Waltham, MA, 02451-1457

    Description

    PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Product Code: 5002-0500 Specimen Gate Screening Center is intended for use as a data processing module in the storage, retrieving, and processing of laboratory data.

    Reason

    Potential for demographic information and test result to be mismatch.

    Action

    PerkinElmer sent an Urgent Medical Device Recall letter on July 1, 2014, to all affected customers. The letter informed customers of the recall and provided instructions. Customers were asked to complete the enclosed response form and fax it to 1-330-825-8520. For additional information, customers were instructed to contact their local PerkinElmer representative or email [email protected]. Customers with questions were instructed to call 1-800-321-9632. option 1.

    Distribution

    Worldwide Distribution - USA including MA, GA, FL, NV, and Internationally to Canada, Ireland, Italy, Saudi Arabia, Belgium, and UK

    Quantity

    13 devices