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U.S. Department of Health and Human Services

Class 2 Device Recall MYLA server HP Proliant

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  Class 2 Device Recall MYLA server HP Proliant see related information
Date Initiated by Firm April 14, 2015
Date Posted May 15, 2015
Recall Status1 Terminated 3 on December 13, 2017
Recall Number Z-1621-2015
Recall Event ID 71049
Product Classification unknown device name - Product Code N/A
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).
Code Information Ref. #415603 and 411402
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact Ryan LeMelle
314-731-8582
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Software design
Action Consignees were notified electronically on April 14, 2015 and letter via FedEx on 04/20/2015.
Quantity in Commerce 730 units
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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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