BioMerieux SA Recall 88658
Description: MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
BioMerieux SA Recall 88658 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0084-2022 |
| Event ID | 88658 |
| Event Description | MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System |
| Product Type | Devices |
| 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. |
| Quantity | 542 units |
| Recall Reason | Under certain conditions, there is a risk for a false negative result. |
| Device Classification | 20211020 |
| Device Code Info | MYLA Software version 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2 |
| Center Classification Date | 20211008 |
| Recall Initiation Date | 20210902 |
| Recalling Firm | BioMerieux SA |
| Initial Notification | Letter |
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