Recall Z-1640-2022— bioMerieux, Inc.
Class II · Ongoing
Class II FDA medical device recall by bioMerieux, Inc., initiated 2022-07-13. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: There are 7 reported software anomalies that may affect use of the device..
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-07-13
- Firm location
- Durham, NC, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.