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.
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Distribution in the U.S. was nationwide. There was also military and government distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2225-2021