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
Reported: September 7, 2022 Initiated: July 13, 2022 #Z-1640-2022
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
Reason for Recall
There are 7 reported software anomalies that may affect use of the device.
Details
- Recalling Firm
- bioMerieux, Inc.
- Distribution
- International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam.
- Location
- Durham, NC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by bioMerieux, Inc..
Why was this product recalled? ▼
There are 7 reported software anomalies that may affect use of the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 7, 2022. Severity: Moderate. Recall number: Z-1640-2022.
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