Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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 Recall Z-1640-2022 · Posted None

Recalling FirmbioMerieux, Inc.
Recall StatusOpen, Classified
Product CodeNSX
Date Initiated2022-07-13

Reason for Recall

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

Firm 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).

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑