VITEK® 2 COMPACT 27560Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03573026136796), received between Sep 17, 2019 and Oct 27, 2022 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (15 reports).

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (K050002); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

1. 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-1308-2021 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2022Application Program Problem; Application Program Problem

  INTENDED USE: THE VITEK® 2 SYSTEM IS INTENDED FOR THE AUTOMATED QUANTITATIVE OR QUALITATIVE ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ISOLATED COLONIES FOR MOST CLINICALLY SIGNIFICANT AEROBIC GRAM-NEGATIVE BACILLI, STAPHYLOCOCCUS SPP., ENTEROCOCCUS SPP., STREPTOCOCCUS SPP., AND YEAST. THE VITEK® 2 SYSTEM IS ALSO INTENDED FOR THE AUTOMATED IDENTIFICATION OF MOST CLINICALLY SIGNIFICANT ANAEROBIC ORGANISMS AND CORYNEBACTERIUM SPECIES, FERMENTING AND NONFERMENTING GRAM-NEGATIVE BACILLI, GRAM-POSITIVE ORGANISMS, FASTIDIOUS ORGANISMS, AND YEASTS AND YEAST-LIKE ORGANISMS. ISSUE DESCRIPTION: A CUSTOMER IN COLOMBIA NOTIFIED BIOMÉRIEUX OF OBTAINING DELAYED RESULTS GREATER THAN 24 HOURS WHILE USING THE PRODUCT VITEK 2 COMPACT 60 (REF. 27560, SERIAL NUMBER (B)(4)). IT WAS REPORTED THAT THE CUSTOMER WAS NOT ABLE TO VIEW THE RESULTS OF A SPECIFIC ISOLATE DUE TO "ERROR - THE ISOLATE COULD NOT BE FOUND OR THERE WAS AN ERROR WHEN RETRIEVING IT" AND IT DOES NOT ALLOW VIEWING THE ISOLATE. THE CUSTOMER WAS REQUIRED TO SET UP A NEW CARD. AS IT WAS REPORTED THAT CUSTOMER HAD TO RE-SUB THE ORGANISM AND THEN SET UP A NEW CARD, IT¿S UNDERSTOOD THAT RESULTS WERE DELAYED GREATER THAN 24 HOURS. ACCORDING TO BIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15682896 ↗
• MalfunctionNov 25, 2020Communication or Transmission Problem; Communication or Transmission Problem

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF AN ISSUE WHERE THERAPEUTIC CORRECTIONS (TC) WERE NOT BEING SENT TO LABORATORY INFORMATION SYSTEM (LIS) USING THE VITEK® 2 COMPACT (REFERENCE # 27560, SERIAL # (B)(4)). USER COMPLAINED ABOUT AN HL7 CONNECTION WITH THE LIS WHERE THE THERAPEUTIC CORRECTIONS WERE NOT SENT TO LIS. THEY SAW THAT ONLY NON-EXPERTIZED RESULTS WERE SENT TO LIS INSTEAD OF EXPERTIZED RESULTS. THEY INDICATED THAT NO WRONG RESULTS WERE GIVEN TO THE PHYSICIAN AND THAT SINCE THE BEGINNING OF THIS ISSUE THEY VERIFIED EACH RESULT MANUALLY ON THE LIS UNTIL THEY CAN FIND A SOLUTION. THE EXPERT UNIT WAS ABLE TO RECREATE THIS ISSUE. THEY DETERMINED THAT ANTIBIOTICS WITH A THERAPEUTIC CORRECTION ARE NOT BEING SENT TO THE LIS AS EXPECTED. WHEN ISOLATE RESULTS ARE SENT TO THE LAB INFORMATION SYSTEM (LIS) VIA HL7 FOR THE FIRST TIME, THERE IS NO PROBLEM. HOWEVER, IF THE ISOLATE IS SENT MORE THAN ONCE TO THE LIS, THEN THE SYSTEM DOES NOT SEND THE EXPERTISED (CORRECTED) INTERPRETATION RESULT. THIS IS TRUE FOR ALL CASES OF THERAPEUTIC CORRECTIONS: PHENOTYPE, FORCING RULE, AND BIOLOGIC CORRECTION. A PHYSICIAN MAY NOT REALIZE THAT AN ANTIBIOTIC SHOULD NOT BE USED. FOR CLARIFICATION, THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10901371 ↗
• MalfunctionSep 26, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR (B)(6) WHEN PERFORMING ANTIMICROBIAL SUSCEPTIBILITY TESTING (AST) WITH THE VITEK® 2 COMPACT 60 AFTER A SOFTWARE VERSION UPGRADE TO 8.01. THE SPECIFIC AST CARD TYPE AND LOT INFORMATION WERE NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER IS USING THE DISK DIFFUSION METHOD TO VERIFY THE SUSCEPTIBILITY RESULTS FOR (B)(6) ISOLATES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9126156 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100807 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM GREAT BRITAIN REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100804 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100803 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100802 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100801 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100800 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100799 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100798 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100797 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100796 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100795 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100794 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. (B)(4)) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100793 ↗
• MalfunctionSep 20, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER SITE, RE-INSTALLED VITEK 2 V8.01 SYSTEMS SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE PATIENT RESULTS WERE DELAYED BY MORE THAN 24 HOURS. NO INCORRECT RESULT WAS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DELAYED RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9100791 ↗
• MalfunctionSep 17, 2019Computer Software Problem; Computer Software Problem

  A CUSTOMER FROM (B)(6) REPORTED THAT VITEK® 2 GN ID AND AST-GN86 CARDS WERE STUCK IN PRELIMINARY STATUS IN THE VITEK 2 COMPACT 60 (REF. 27560) INSTRUMENT WHEN TESTING PATIENT SAMPLES. THE CUSTOMER STATED THERE WAS NO ERROR MESSAGE AND RESULTS WERE NOT COMPLETE. AFTER TRYING TO RE-RUN CARDS AT BIOMÉRIEUX'S REQUEST, THE CUSTOMER STATED THAT THE SYSTEM WAS COMPLETELY DOWN AND NOT FUNCTIONAL. A BIOMÉRIEUX FIELD ENGINEER INTERVENED AT THE CUSTOMER'S SITE, RE-INSTALLED VITEK 2 V8.01 SOFTWARE AND THE CUSTOMER REPORTED THAT VITEK 2 WAS WORKING PERFECTLY. THE CUSTOMER REPORTED THAT THE RESULTS FOR 15 PATIENTS WERE DELAYED BY MORE THAN 24 HOURS, AND IMPACTED TREATMENT OF ONE PATIENT. THERE WERE NO WRONG RESULTS REPORTED. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT 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 9077562 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050002. One submission often covers many models, so check the product and lot details in each record.

• Z-1307-2021 · Jan 28, 2021 · Terminated
  VITEK 2 (version numbers 8.01, 8.02 (8.0x) and 9.01, 9.02 (9.0x) with the external communication configured to HL7 (system, test, automated, antimicrobial susceptibility, short inc
• Z-0639-2019 · Nov 13, 2018 · Terminated
  VITEK 2 Systems Software Version 9.01 Update Kit.
• Z-3075-2017 · Jul 12, 2017 · Terminated
  VITEK 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial susceptibility testing (AST) of bacteria and ye
• Z-3076-2017 · Jul 12, 2017 · Terminated
  VITEK 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for the identification (ID) and antimicrobial sus
• Z-0991-2013 · Feb 18, 2013 · Terminated
  VITEK 2 Compact computer system when equipped with the following Hewlett-Packard PC models: (1) dc7100 8-port, Cat. #W0441; (2) dc7100 8-port (refurbished), Cat. #W0441R; (3) dc