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.
Reported: August 18, 2021 Initiated: June 22, 2021 #Z-2225-2021
Product 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.
Reason for Recall
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Details
- Recalling Firm
- BioMerieux SA
- Units Affected
- 248 systems
- Distribution
- Distribution in the U.S. was nationwide. There was also military and government distribution.
- Location
- Marcy L'Etoile, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by BioMerieux SA. Units affected: 248 systems.
Why was this product recalled? ▼
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Moderate. Recall number: Z-2225-2021.
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