BEUDAMED
    FDA Recall Terminated

    Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports

    Recall: Z-0902-2017 · Initiated December 1, 2016

    Recall

    Recall Number
    Z-0902-2017
    Event Number
    75817
    Firm
    PerkinElmer Health Sciences, Inc.
    FEI Number
    3006159931
    Product Code
    JQP
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 1, 2016
    Posted
    December 23, 2016
    Terminated
    May 1, 2017
    Address
    940 Winter St, Waltham, MA, 02451-1457

    Description

    Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use as a data processing software used in the storage, retrieving, and processing of laboratory data. Specimen Gate eReports Software is a module of Specimen Gate Laboratory that functions to support newborn screening laboratories, hospitals, clinical and physicians in data management and generating reports

    Reason

    Issue may cause eReports to consume an excessive amount of disk space causing the software to stop operating.

    Action

    PerkinElmer Health Sciences issued a Medical Device Correction letter dated December 1, 2016, to all affected customers email facilitated through our PerkinElmer Software Services group located in Akron Ohio. Software Services will be asked to make sure the customers receive the Recall Letter and implement the recommended corrective measures. Actions to be taken A field correction of the issue is recommended. PerkinElmer will correct the issue with an update installed through remote connection. You will be contacted by your PerkinElmer representative to make the necessary arrangements for implementing the update. In the interim period, please do not attempt to login multiple times in quick succession. Allow the software time to respond to first login command. Please contact your local PerkinElmer representative or Specimen Gate Support for further information. Other Information Please inform those affected in your organization accordingly. To comply with regulatory requirements we request that you complete the enclosed response form and return it by fax to number 1-330-825-8520 (United States) /+358 2 2678 357 (outside United States) or as scanned by e-mail to [email protected] as soon as possible, but not later than December 22, 2016. For questions regarding this recall call 781-663-6900.

    Distribution

    Worldwide Distribution - US including CO, FL, GA, IL, MA, MI, NV, NJ, OH, SC, AZ, KY and Internationally to Italy, Ireland, UK, Spain, and Peru

    Quantity

    21