Recall Z-1621-2015— bioMerieux, Inc.
Class II · Terminated
Class II FDA medical device recall by bioMerieux, Inc., initiated 2015-04-14, terminated 2017-12-13. FDA's recall record names no specific 510(k) clearance for this event. 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).. 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.
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-14
- Terminated
- 2017-12-13
- Firm location
- Durham, NC, United States
Product 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 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.