VITEK® 2 COMPACT 27530Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03573026136789), received between Jan 3, 2020 and Aug 14, 2026 — classified as 5 malfunctions.

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

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 18, 2026.

Recalls naming this device

1. Jan 28, 2021Class IITerminated

   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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2026Data Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50257523 ↗
• MalfunctionDec 1, 2022High Test Results; High Test Results

  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 NON-FERMENTING GRAM-NEGATIVE BACILLI, GRAM-POSITIVE ORGANISMS, FASTIDIOUS ORGANISMS, AND YEASTS AND YEAST-LIKE ORGANISMS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN SPAIN NOTIFIED BIOMERIEUX OF OBTAINING FALSE RESISTANT RESULTS WHEN USING THE VITEK 2 COMPACT 30 - REFERENCE (B)(4) ( SERIAL NUMBER (B)(4)). AT THE MOMENT, IT HAS NOT BEEN NOTIFIED WHICH STRAINS OR ANTIMICROBIALS ARE CONCERNED BY THE FALSE RESISTANT RESULTS. THE CUSTOMER INDICATES THAT ALTERNATE METHOD AND REPEAT TESTING HAVE BEEN PERFORMED TO CONFIRM THE EXPECTED SUSCEPTIBLE RESULTS. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO ANY DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR THE CONCERNED PATIENT. THIS DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15892743 ↗
• MalfunctionOct 26, 2022Decreased Sensitivity; Decreased Sensitivity

  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 NON-FERMENTING GRAM-NEGATIVE BACILLI, GRAM-POSITIVE ORGANISMS, FASTIDIOUS ORGANISMS, AND YEASTS AND YEAST-LIKE ORGANISMS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN INDIA NOTIFIED BIOMÉRIEUX OF HAVING CARD TERMINATION ISSUES WITH THEIR VITEK 2 COMPACT (REF. 27530, SERIAL NUMBER (B)(4) RESULTING IN DELAY IN REPORTING RESULTS FOR TWENTY (20) PATIENT ISOLATES. THE CUSTOMER STATED ALL CARDS LOADED (B)(6) 2022 WERE TERMINATED DUE TO THE OPTICS BEING OUT OF CALIBRATION. INDIA LOCAL CUSTOMER SERVICE (LCS) HAD THE CUSTOMER CLEAN THE OPTICS AND ALSO CONNECTED TO THE SYSTEM VIA REMOTE DIAGNOSTICS TO CHECK THE OPTICS STATUS. THE OPTICS PASSED THE CAL COMMAND; HOWEVER, THE DAC VALUES WERE LOW. THE VALUES DISPLAYED WITH THE READ COMMAND WERE ALSO LOW. LCS D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672240 ↗
• MalfunctionMar 9, 2021No Device Output; No Device Output

  A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A MISSING ISOLATE IN ASSOCIATION WITH THE VITEK® 2 COMPACT 30 (REF. 27530, SERIAL NUMBER (B)(4) ), THE VITEK 2 GP ID CARD (REF. 21342, LOT UNKNOWN) AND SOFTWARE VERSION 9.02. THE CUSTOMER OBTAINED A LOW-DISCRIMINATION RESULT AND STATED WHEN THEY TRIED TO OPEN THE ISOLATE RECORD THEY OBTAINED AN ERROR MESSAGE STATED ¿CANNOT FIND THE ISOLATE.¿ THE CUSTOMER RESTARTED THE SYSTEM; THE SAME ERROR MESSAGE WAS OBTAINED WHEN ATTEMPTING TO OPEN THE ISOLATE RECORD. IT IS UNKNOWN IF THE INABILITY TO REVIEW THE ISOLATE RESULTED IN A DELAY OF REPORTING RESULTS. BIOMERIEUX HAS REQUESTED THE CUSTOMER DATA LOGS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. BIOMERIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11447029 ↗
• MalfunctionJan 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEX OF FALSE RESISTANT RESULTS AND DELAYS IN REPORTING RESULTS FOR PATIENT ISOLATES IN ASSOCIATION WITH THE VITEK® 2 COMPACT 30 (REF 27530, SERIAL (B)(4)). THE CUSTOMER STATED THAT THE MAJORITY OF THEIR PATIENT ISOLATES WERE OBTAINING RESISTANT RESULTS ON THE VITEK® 2. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE RESISTANT RESULTS OR DELAYS LED TO ANY ADVERSE EVENTS 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 9547285 ↗

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