MYLA Versions: 4.7 recall
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Why was MYLA Versions: 4.7 recalled?
Under certain conditions, there is a risk for a false negative result.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2
- Product
- MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
- Recalling firm
- BioMerieux SA
- Quantity
- 542 units
- 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.
- Recall date
- October 20, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)