FDA Enforcement
Class II
Ongoing
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: Z-1640-2022
·
Reported September 7, 2022
Enforcement
- Recall Number
- Z-1640-2022
- Event ID
- 90605
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- bioMerieux, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Report Date
- September 7, 2022
- Initiation Date
- July 13, 2022
- Classification Date
- August 26, 2022
- Address
- 100 Rodolphe St, Durham, NC, 27712-9402, United States
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
Reason
There are 7 reported software anomalies that may affect use of the device.
Code Info
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
International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.