Recall Z-1640-2022 ยท NSX
bioMerieux, Inc.
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
| Date | Jul 13, 2022 |
| Status | Open, Classified |
| Reason | There are 7 reported software anomalies that may affect use of the device. |
| Root cause | Software design |
| Action | Recall notification was issued on or around July 13, 2022. Subsidiaries/distributors are instructed to identify/notify any impacted customer(s) in their region(s) of responsibility. Each customer is requested to return an Acknowledgement Form indicating that they are in receipt of the letter and will comply with the required actions (as appropriate to their laboratory). |
| Distribution | International distribution to the countries of Estonia, Bahrain, Pakistan, UK, Singapore, Saudi Arabia, Thailand, and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.