BioMerieux SA Recall 87985
Description: MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data.
BioMerieux SA Recall 87985 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2225-2021 |
| Event ID | 87985 |
| Event Description | MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and displaying medical device data. |
| Product Type | Devices |
| Distribution | Distribution in the U.S. was nationwide. There was also military and government distribution. |
| Quantity | 248 systems |
| Recall Reason | Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature. |
| Device Classification | 20210818 |
| Device Code Info | MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975. |
| Center Classification Date | 20210806 |
| Recall Initiation Date | 20210622 |
| Recalling Firm | BioMerieux SA |
| Initial Notification | Letter |
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