Device product
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.
Z-2225-2021
Product summary
- Firm
- BioMerieux SA
- Event
- Event 87985
- Status
- Terminated
- Classification
- Class II
- Quantity
- 248 systems
- Official record key
device-enforcement:Z-2225-2021
Official wording
Reason: Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Code information: MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975.
Distribution pattern: Distribution in the U.S. was nationwide. There was also military and government distribution.
Derived failure modes
-
Device software or design
Software anomaly