Class 2 Device Recall MYLA software V4.8.X and V4.9

• Date Initiated by Firm: February 06, 2023
• Date Posted: March 02, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1201-2023
• Recall Event ID: 91617
• Product Classification: Medical device data system - Product Code OUG
• Product: MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and blood culture activities and the laboratory information system (LIS).
• Code Information: Versions 4.7 and 4.8
• Recalling Firm/ Manufacturer: Biomerieux Inc; 595 Anglum Rd; Hazelwood MO 63042-2320
• For Additional Information Contact: Clinical Customer Support; 800-682-2666
• Manufacturer Reason for Recall: For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the clinician.
• FDA Determined Cause: Software design
• Action: BioMerieux, US subsidiary issued an URGENT FIELD SAFETY NOTICE to its consignees beginning on 02/06/2023 by email and letter. The notice explained the issue with the product and potential risk, and requested the use take the following actions: "1. Confirm this letter has been distributed to and reviewed by all appropriate personnel within your organization. 2. If you are using VITEK MS as part of your laboratory workflow AND you currently use MYLA AST Filter rules disable current MYLA AST Filter rules. Review AST results to determine if some results should be suppressed from reporting. 3. If you are currently using MYLA AST Filter rules WITHOUT VITEK MS as part of your laboratory workflow, there is no impact and no action is required. 4. If you are not currently using MYLA AST Filter rules WITH or WITHOUT VITEK MS as part of your laboratory workflow, there is no impact and no action is required. 5. If you PLAN to use MYLA AST Filter rules WITH VITEK MS as part of your laboratory workflow in the future, please wait to begin usage of the MYLA AST Filter rules until MYLA version 4.9.1 has been installed on your systems. MYLA AST Filter rules may be activated at any time for workflows that do not include VITEK MS. 6. Once the patch to MYLA version 4.9.1 has been installed, usage of MYLA AST Filter Rules with VITEK MS as part of the laboratory workflow may resume. 7. Complete the attached Acknowledgement Form and return it to your local bioMrieux representative as soon as possible."
• Quantity in Commerce: 19 systems
• Distribution: US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.
• 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.