—#135926

Product

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).

FDA product code: N/A
Affected lot / code info: Ref. #415603 and 411402

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2015-04-14
Posted by FDA: 2015-05-15
Terminated: 2017-12-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #135926. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.