Recall of Device Recall MYLA

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by bioMerieux, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Calculator/data processing module, for clinical use - Product Code JQP
  • 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.
  • Action
    bioMerieux sent an Urgent Product Correction Notice letter dated November10, 2015 via FedEx to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact your local bioM¿rieux Clinical Customer Service organization at (800) 682-2666.


  • Model / Serial
    REF # 419071, Serial number/Software version V4.1 CLI
  • Product Classification
  • Device Class
  • Implanted device?
  • 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.
  • Product Description
    MYLA CLI V3.X TO V4.1 DL380 SERVER || 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)).
  • Manufacturer


  • Manufacturer Address
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • Manufacturer Parent Company (2017)
  • Source