BEUDAMED
    FDA Recall Terminated

    MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s).

    Recall: Z-1621-2015 · Initiated April 14, 2015

    Recall

    Recall Number
    Z-1621-2015
    Event Number
    71049
    Firm
    bioMerieux, Inc.
    FEI Number
    3002769706
    Product Code
    N/A
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 14, 2015
    Posted
    May 15, 2015
    Terminated
    December 13, 2017
    Address
    100 Rodolphe St, Durham, NC, 27712-9402

    Description

    MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software. MYLA V3 is a computer application ("Middleware") based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s).

    Reason

    The MYLA server could slow down due to the volume (weight) of the data to manage and it could also stop processing, impacting the server start-up phase. The problem occurs in high volume settings. The MYLA server slows down and will stop processing completely if any task requires more than 5 minutes to complete. The server then fails to reboot and requires service, provided remotely or on-site

    Action

    Consignees were notified electronically on April 14, 2015 and letter via FedEx on 04/20/2015.

    Distribution

    Worldwide Distribution-Algeria, Argentina, Australia, Austria, Brazil Canada, Chile China, Colombia, Czech Republic, France Germany , Greece, Hungary, India, Italy Japan, Korea, Mexico, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Angola, Armenia, Kocaeli, Bahrain, Bangladesh, Republic of Belarus, Benin, Bolivia, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Germany Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Georgia, Guam, Guatemala, Guinea, Honduras, Indonesia, Iran, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Malta, Morocco, Portugal, Myanmar, Managua, Niger, Nigeria, Oman, Palestine, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Kingdom of Saudi Arabia, Senegal, Slovakia, Sri Lanka, Tanzania, Togo, Tunisia, Ukraine, UAE, Uraguay, Venezuela, Vietnam, Yemen and Zimbabwe.

    Quantity

    730 units