VITEK2Recalls & reported problems across all models

We found 5 models of VITEK2 by Biomerieux , Inc. in the FDA's device registry (GUDID). Together they are named in 2 adverse event reports in the FDA's MAUDE database, 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).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

VITEK2 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 13, 2022Open, Classified

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

   Z-1640-2022 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

2. Jan 28, 2021Terminated

   bioMrieux has identified a potential safety risk worst case of a false susceptible erroneous test result associated with this event. The problem is when HL7 Connection is used, the results in the VITEK 2 do not match the results sent to the LIS and the Laboratory Technician would need to change results in the LIS to match those in the VITEK 2. If the isolate is sent more than once to LIS, a software defect prevents the system from sending the expertised interpretation results and the Therapeutic Corrections (TC) is not sent to Laboratory Information Systems (LIS).

   Z-1307-2021 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

Most reported VITEK2 problems

VITEK2 models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VITEK®2 27225R

  System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
  1 recall0 reports
• VITEK®2 27227R

  System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
  1 recall0 reports
• VITEK®2 8.01

  System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
  1 recall0 reports
• VITEK®2 9.01.1

  SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
  1 recall0 reports
• VITEK®2 27222R

  System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
  2 reports

Recent VITEK2 adverse event reports

The 2 most recent reports across all models, 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 ↗

Other Biomerieux , Inc. products

• BACT/ALERT VIRTUO2 models · 41 reports · 2 recalls
• VITEK 2 COMPACT3 models · 25 reports · 1 recall
• VITEK2 Compact3 models · 0 reports · 1 recall