VITEK®2 27222RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026145842), received between Jan 3, 2019 and Oct 3, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2019Communication or Transmission Problem; Communication or Transmission Problem

  A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF VITEK® 2 CARD DATA MISSING WHEN TESTING PATIENT ISOLATES WITH THE VITEK® 2 XLR MODULE COLORM 110V. THE CUSTOMER STATED THAT SOME CARDS ARE NOT DISPLAYING IN THE VITEK® 2 APPLICATION. THE CUSTOMER MAY LOAD A FULL CASSETTE, BUT SOME CARDS ARE NOT SHOWING UP IN THE SOFTWARE THE NEXT DAY WHEN THE RESULTS ARE CHECKED. THE ISSUE LED TO A DELAY OF >24 HOURS FOR SOME TEST RESULTS, BUT NO INCORRECT RESULTS WERE OBTAINED AND THERE WAS NO PATIENT INJURY OR INAPPROPRIATE TREATMENT DUE TO THE DELAY. THE CUSTOMER DID NOT PROVIDE THE NUMBER OF PATIENTS FOR WHICH TEST RESULTS WERE DELAYED. AFTER THE INITIAL COMPLAINT, THE CUSTOMER BEGAN MONITORING FOR ANY ADDITIONAL MISSING CARD DATA. AFTER FOUR WEEKS OF MONITORING, THERE WAS NOT A RECURRENCE OF THE ISSUE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9152594 ↗
• MalfunctionJan 3, 2019Communication or Transmission Problem; Communication or Transmission Problem

  A CUSTOMER IN THE UNITED STATES REPORTED THAT PATIENT TEST CARDS ASSOCIATED WITH THE VITEK® 2 XLR MODULE COLORM 110V DID NOT SHOW UP IN THE SOFTWARE. CARDS LOADED INTO THE INSTRUMENT ON (B)(6) 2018 AND (B)(6) 2018, DID NOT SHOW UP IN THE SOFTWARE. THE DATA FOLDERS WERE EMPTY SO THE INSTRUMENT AND PC WERE REBOOTED WITHOUT ERROR, AND THE DATA FOLDERS REMAINED EMPTY. THE CUSTOMER MENTIONED THAT ELEVEN CARDS WERE LOADED ON (B)(6) 2018, AND ONLY ONE CARD WAS TERMINATED IN EACH CAROUSEL, WITH FOUR CARDS IN THE WASTE TRAY. IN THE DIAGNOSTIC TERMINAL, CARDS LOADED ON (B)(6) 2018 DID NOT SHOW IN CAROUSELS, AND ONLY SHOWED ONE TERMINATED IN EACH CAROUSEL. THE CUSTOMER REPORTED THAT PATIENT RESULTS WERE DELAYED GREATER THAN 24 HOURS FROM THE EXPECTED REPORTING TIME FRAME. THE CUSTOMER STATED THAT NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8212655 ↗