MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments
Summary
The FDA issued a Class II for MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connec by Biomerieux Inc. Reason: 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.
Details
Source
Device Recall
External ID
Z-1201-2023
Action Date
2023-03-08
Status
Ongoing
Category
device
Product Description
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).
Lot/Code Info: Versions 4.7 and 4.8
Quantity Affected: 19 systems
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.
Distribution
US Nationwide distribution to the states of Alabama, California, North Carolina, and Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-06
Company
Hazelwood, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Biomerieux Inc has 146 FDA actions in our database, including 122 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Biomerieux Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Biomerieux Inc have FDA actions?
Biomerieux Inc has 146 FDA actions in our database, including 122 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1201-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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