VITEK 2 Systems and VITEK 2 with MYLA.

Reason: Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.

Code information: VITEK 2 - Versions 8.01, 9.01, 9.02 (with or without 9MR2), 9.03 (with or without #9MR2). VITEK 2 with MYLA - Versions 4.8 and 4.9.

Distribution pattern: U.S. distribution of the FSCA to NC. OUS distribution of the FSCA to subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Serbia, Sweden, Singapore, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, and United Kingdom.