MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Summary
The FDA issued a Class II for MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System by BioMerieux SA. Reason: Under certain conditions, there is a risk for a false negative result..
Details
Source
Device Recall
External ID
Z-0084-2022
Action Date
2021-10-20
Status
Terminated
Category
device
Product Description
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Lot/Code Info: MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2
Quantity Affected: 542 units
Reason for Recall
Under certain conditions, there is a risk for a false negative result.
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Austria, Australia, Belgium, Canada, Switzerland, Chile, Columbia, Czech Republic, Denmark, Germany, Spain, Finland, France, United Kingdom, Guadeloupe, Hong Kong, Canary Islands, Ireland, India, Italy, Japan, South Korea, The Netherlands, Norway, Poland, Portugal, Sweden, Singapore, South Africa.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-02
Company
La Balme les Grottes, N/A
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 174 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BioMerieux SA has 2 FDA actions in our database, including 2 recalls.
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 SA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioMerieux SA have FDA actions?
BioMerieux SA has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0084-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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