—#198358

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).

FDA product code: OUG — Medical Device Data System
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: Versions 4.7 and 4.8

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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."

Recalling firm

Firm: Biomerieux Inc
Address: 595 Anglum Rd, Hazelwood, Missouri 63042-2320

Distribution

Distribution pattern: US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.

Timeline

Recall initiated: 2023-02-06
Posted by FDA: 2023-03-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198358. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.