BEUDAMED
    FDA Enforcement Class II Terminated

    MYLA MASTER DVD V4.0 CLI Product Usage: MYLA 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-0428-2016 · Reported December 23, 2015

    Enforcement

    Recall Number
    Z-0428-2016
    Event ID
    72643
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    bioMerieux, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 23, 2015
    Initiation Date
    November 3, 2015
    Classification Date
    December 16, 2015
    Termination Date
    December 4, 2017
    Address
    100 Rodolphe St, N/A, Durham, NC, 27712-9402, United States

    Description

    MYLA MASTER DVD V4.0 CLI Product Usage: MYLA 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

    MYLA¿ software connected to a Laboratory Information System (LIS) and a VITEK¿ 2 system has the potential to link a test result to an incorrect patient record with the same specimen ID.

    Code Info

    REF # 416546, Serial number/Software version V4.0 CLI

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and countries of: Foreign accounts: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Japan, Korea, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, Angola, Puerto Rico, Republic of Belarus, Republic of Belarus, Benin, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Guam, Guatemala, Guatemala, Guinea, Honduras, Indonesia, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malaysia, Mali, Portugal, Myanmar, Managua, Niger, Nigeria, Palestine, Philippines, Philippines, Qatar, Kingdom of Saudi Arabia, Senegal, Serbia, Slovakia, Togo, Tunisia, Ukraine, UAE, Vietnam, Vietnam, Ivory Coast and Zimbabwe.

    Quantity

    626 systems in total