—#195034

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

FDA product code: NSX
Affected lot / 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

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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).

Recalling firm

Firm: bioMerieux, Inc.
Address: 100 Rodolphe St, Durham, North Carolina 27712-9402

Distribution

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

Timeline

Recall initiated: 2022-07-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195034. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.