Z-2225-2021 Class II Terminated
FDA device recall Z-2225-2021 was initiated by BioMerieux SA on June 22, 2021 and is designated Class II. Reason for recall: Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature. The recall status is terminated (terminated February 6, 2023). Affected quantity: 248 systems.
Recall Details
- Product Type
- Devices
- Report Date
- August 18, 2021
- Initiation Date
- June 22, 2021
- Termination Date
- February 6, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 248 systems
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.
Distribution Pattern
Distribution in the U.S. was nationwide. There was also military and government distribution.
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.