25
May
2022

Recall – Lab results did not include correct interpretation

,
0

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

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