bioMerieux, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1640-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 13, 2022

Date Posted: September 7, 2022

Recall Number: Z-1640-2022

Event ID: 90605

Reason for Recall:

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

Status: Ongoing

Product Quantity:

Code Information:

VITEK 2 Software Versions 8.01, 8.02 (veterinary only), 9.01, 9.02, 9.03 / MYLA Software Versions V4.8, V4.9 UDI/GTIN: 03573026553968, 03573026619060, 03573026609399, 03573026613914, 03573026619244, 03573026621568

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated