FDA-Device2022-05-18Class II
VITEK 2 Systems and VITEK 2 with MYLA.
bioMerieux, Inc.
Hazard
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.
Sold states
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.
Affected count
21,757 systems
Manufactured in
100 Rodolphe St, N/A, Durham, NC, United States
Products
VITEK 2 Systems and VITEK 2 with MYLA.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1059-2022Don't want to check this manually?
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