MYLA software. Used to manage microbiology test recall: Software Issue
MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and…
Why was MYLA software. Used to manage microbiology test recalled?
Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
MYLA V4.8.0/4.8.1 and MYLA V4.7.0/V4.7.1 in conjunction with BCI CONNECT, UDI 03573026619244 and 03573026610975.
- Product
- MYLA software. Used to manage microbiology test workflow from the reception of requests to the transmission of results by transferring, storing, and…
- Recalling firm
- BioMerieux SA
- Quantity
- 248 systems
- Distribution
- Distribution in the U.S. was nationwide. There was also military and government distribution.
- Recall date
- August 18, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)