bioMerieux, Inc. recalls VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V

Recalled September 7, 2022 · FDA recall Z-1640-2022 · bioMerieux

Hazard

There are 7 reported software anomalies that may affect use of the device. · FDA Class II

Sold at

International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.

Description

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

Product

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

Manufacturer(s)

bioMerieux, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →