Company: bioMerieux, Inc.
Date of Enforcement Report: 5/25/2022
VITEK 2 automated system.
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests to not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final screen/synergy test results at the LIS.
bioMerieux, Inc. on 5/25/2021. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
74 systems using v8.02
U.S. Nationwide and International