Company: bioMerieux, Inc.
Date of Enforcement Report: 5/25/2022
Class II
PRODUCT
VITEK 2 automated system.
Recall Number:
V-0141-2022
REASON
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.
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc. on 5/25/2021. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
74 systems using v8.02
DISTRIBUTION
U.S. Nationwide and International