Recall – Lab results did not include correct interpretation

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

Latest News!

Updated Risk Management training course now available.  Includes:

  • Coverage of ISO 14971, IEC 62304; amd1, and IEC/TR 80002-1.
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.  Contact training@softwarecpr.com

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.