Z-0084-2022 Class II Terminated
FDA device recall Z-0084-2022 was initiated by BioMerieux SA on September 2, 2021 and is designated Class II. Reason for recall: Under certain conditions, there is a risk for a false negative result. The recall status is terminated (terminated March 9, 2026). Affected quantity: 542 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 20, 2021
- Initiation Date
- September 2, 2021
- Termination Date
- March 9, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 542 units
Product Description
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Reason for Recall
Under certain conditions, there is a risk for a false negative result.
Distribution Pattern
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.
Code Information
MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2