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.
Check against the official notice below — it lists the full affected range.
BioMerieux SA has recalled MYLA software versions 4.8.0, 4.8.1, 4.7.0, and 4.7.1 used in conjunction with BCI Connect. The software manages microbiology test workflows by transferring, storing, and displaying medical device data. A software anomaly in the BCI Connect scripting feature could cause unwanted alterations to test results under certain conditions. Approximately 248 systems were affected nationwide, including systems distributed to military and government facilities.
The record does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Reason for recall: Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature. Distribution: Distribution in the U.S. was nationwide. There was also military and government distribution. Quantity: 248 systems Lot/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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.