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U.S. Department of Health and Human Services

Class 2 Device Recall VITEK and MYLA

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  Class 2 Device Recall VITEK and MYLA see related information
Date Initiated by Firm March 29, 2022
Create Date May 11, 2022
Recall Status1 Open3, Classified
Recall Number Z-1059-2022
Recall Event ID 89929
Product Classification System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
Product VITEK 2 Systems and VITEK 2 with MYLA.
Code Information VITEK 2 - Versions 8.01, 9.01, 9.02 (with or without 9MR2), 9.03 (with or without #9MR2). VITEK 2 with MYLA - Versions 4.8 and 4.9.
Recalling Firm/
Manufacturer		 bioMerieux, Inc.
100 Rodolphe St
Durham NC 27712-9402
For Additional Information Contact bioMerieux Customer Service Center
800-682-2666
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Software design
Action The recalling firm issued Field Safety Corrective Action (FSCA) #5615 dated 29-MAR-2022 to the impacted subsidiaries and distributors. It explained the affected product, issue, and informed the recipient the resolution for the issue has been implemented in VITEK 2 Systems software maintenance release 9MR3 launched 15-MAR-2022 and available in VILINK. It was recommended to convert HL7 users to VITEK 2 Software Version 9.03 and apply the software patch 9MR3 as quickly as possible. Workarounds were provided pending installation of 9MR3 to ensure there are no adverse impact to patients. The FSCA provided a risk assessment/health hazard assessment. The FSCA reported the VITEK 2 Systems software versions 8.01, 8.02, 9.01, 9.02, and 9.03 are available for distribution worldwide, however, only HL7 Protocol users may be impacted by the issue. All subsidiaries and distributors were listed in the FSCA. Their required actions included: (1) Immediately acknowledge receipt of this FSCA; (2) Identify all countries and customers for which they are responsible that are impacted by this FSCA (only HL7/BCI Connect users); (3) Update the enclosed Urgent Product Correction Notice and Customer Acknowledgment Form to include their local contact information and translate them, if necessary; (4) Distribute the Urgent Product Correction Notice and Customer Acknowledgement Form to all VITEK 2 HL7 customers; (5) Determine regulatory reporting requirements in accordance with local regulations and notify regulatory authorities as applicable; (6) The subsidiary/distributor is responsible to monitor action completion at customer sites and determine requirements for local closure of this FSCA in accordance with local regulations and procedures; (7) After all actions are complete, return the acknowledgement of completion for this FSCA. The due date for completion of the required actions and submitting the acknowledgment of completion is 29-JUN-2022. Additionally, Subsidiaries and Distribut
Quantity in Commerce 21,757 systems
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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