VITEK® 2 Software 09.02 9.02.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03573026609399), received between Jan 15, 2021 and Jan 15, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Software Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 13, 2022Class IIOpen, Classified

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

   Z-1640-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2021Computer Software Problem

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A SOFTWARE ISSUE WHILE USING THE VITEK® 2 SYSTEM (REFERENCE # 1950204-2021-00010). THE CUSTOMER UPDATED THEIR SYSTEM FROM (B)(4) IN (B)(6) OF 2020. HOWEVER, IT IS NOW RUNNING A (B)(4) DB ON A (B)(4). THERE WAS NO NOTIFICATION, ANOMALY OR ERROR FROM THE SYSTEM ALERTING THE USER OF THIS CHANGE. PER GLOBAL CUSTOMER SERVICE (GCS), "THIS COMPLAINT WAS CODED PRE DUE TO THE VITEK2 SOFTWARE BACKUP/RESTORE APPLICATION AT (B)(4), ALLOWING A (B)(4) DB TO BE RESTORED. BY DESIGN THE FUNCTION SHOULD HAVE PREVENTED THIS FROM OCCURRING AS THE (B)(4) VERSION WAS NOT A ¿DOU¿ (DATA ONLY UPDATE). IN THE CONFIGURATION SETTINGS IN THE VITEK 2 SOFTWARE, THE VERSION (B)(4) (UDI CODE CONFIRMS) IS DISPLAYED AND IS OPERATING WITH KNOWLEDGE BASE VERSION (B)(4). THE DISPARITY OF VERSIONS COULD RESULT IN THE SYSTEM ANALYSIS USING AN OLDER VERSION OF BREAKPOINTS, AND/OR LIMITATIONS, AND NEGLECT IMPLEMENTATION OF IMPROVEMENTS EXPECTED IN THE (B)(4) KNOWLEDGE BASE."THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THIS SOFTWARE ISSUE HAS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11181301 ↗