Recall Z-0084-2022 ยท OUG Medical Device Data System
BioMerieux SA
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
| Date | Sep 2, 2021 |
| Status | Terminated |
| Reason | Under certain conditions, there is a risk for a false negative result. |
| Root cause | Software design |
| Action | A customer letter was issued to impacted subsidiaries and distributors on 09/08/2021. The letter includes instructions that the customer verify that they operate under the specific conditions required for the anomaly to occur: You are using MYLA (V4.7, V4.7.1, V4.8, V4.8.1 or V4.8.2) in conjunction with BCI Connect AND You are managing Blood Culture analyses on BACT/ALERT VIRTUO connected to MYLA AND Your Blood Culture workflow is based on 2 or more bottles with the same specimen (same specimen/laboratory id) AND You are using the LIS capability to send Blood Culture requests containing the |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.