bioMerieux, Inc. VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

There are 7 reported software anomalies that may affect use of the device.

Recommended Action

Per FDA guidance

Recall notification was issued on or around July 13, 2022. Subsidiaries/distributors are instructed to identify/notify any impacted customer(s) in their region(s) of responsibility. Each customer is requested to return an Acknowledgement Form indicating that they are in receipt of the letter and will comply with the required actions (as appropriate to their laboratory).