Recall Z-0428-2016— bioMerieux, Inc.
Class II · Terminated
Class II FDA medical device recall by bioMerieux, Inc., initiated 2015-11-03, terminated 2017-12-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-03
- Terminated
- 2017-12-04
- Firm location
- Durham, NC, United States
Product 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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.