VITEK® REVEAL™ SENSOR PANELRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00860007326929), received between Mar 24, 2025 and Jun 24, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Unable to Obtain Readings; Appropriate Device Problem Term/Code Not Available; Unable to Obtain Readings; Appropriate Device Problem Term/Code Not Available

  INTENDED USE: THE REVEAL AST SYSTEM IS AN IN-VITRO DIAGNOSTIC (IVD) AUTOMATED SYSTEM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ORGANISMS DIRECT FROM POSITIVE BLOOD CULTURE. THE REVEAL AST ASSAYS ARE INDICATED FOR SUSCEPTIBILITY TESTING OF SPECIFIC PATHOGENIC BACTERIA COMMONLY ASSOCIATED WITH OR CAUSING BACTEREMIA AS WELL AS BACTERIAL ISOLATES FROM OTHER SPECIMEN TYPES. RESULTS ARE INTENDED TO BE USED IN CONJUNCTION WITH GRAM STAIN, ORGANISM IDENTIFICATION AND OTHER CLINICAL LABORATORY FINDINGS. ISSUE DESCRIPTION: A CUSTOMER IN SPAIN NOTIFIED BIOMÉRIEUX OF ¿NO AST RESULTS¿ ISSUES FOR FOUR ANTIBIOTICS WITH ESCHERICHIA COLI IN ASSOCIATION WITH VITEK® REVEAL¿ SENSOR PANEL (20 TESTS) (REF. 900-00002, LOT. UNKNOWN) IT IS UNDERSTOOD THAT CONDENSATION ISSUES HAS BEEN A REOCCURRING PROBLEM FOR THIS CUSTOMER. IT IS VERY UNUSUAL TO HAVE SUCH A MASSIVE AMOUNT OF CONDENSATION IN THE BEGINNING OF THE RUN AND NONE BY THE END. BIOMÉRIEUX ENGINEER AND GLOBAL CUSTOMER SERVICE ARE THEORIZING THAT IF CUSTOMERS ARE SEALING A COLD SENSOR, IT CREATES A TEMPERATURE GRADIENT THAT WILL CAUSE THE CONDENSATION IN THE BEGINNING OF THE RUN. GCS ASKED THE FOLLOWING QUESTIONS TO LOCAL CUSTOMER SERVICE: DO YOU K

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319471 ↗
• MalfunctionJun 24, 2025Unable to Obtain Readings; Appropriate Device Problem Term/Code Not Available; Unable to Obtain Readings; Appropriate Device Problem Term/Code Not Available

  INTENDED USE: THE REVEAL AST SYSTEM IS AN IN-VITRO DIAGNOSTIC (IVD) AUTOMATED SYSTEM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ORGANISMS DIRECT FROM POSITIVE BLOOD CULTURE. THE REVEAL AST ASSAYS ARE INDICATED FOR SUSCEPTIBILITY TESTING OF SPECIFIC PATHOGENIC BACTERIA COMMONLY ASSOCIATED WITH OR CAUSING BACTEREMIA AS WELL AS BACTERIAL ISOLATES FROM OTHER SPECIMEN TYPES. RESULTS ARE INTENDED TO BE USED IN CONJUNCTION WITH GRAM STAIN, ORGANISM IDENTIFICATION AND OTHER CLINICAL LABORATORY FINDINGS. ISSUE DESCRIPTION: A CUSTOMER IN SPAIN NOTIFIED BIOMÉRIEUX OF ¿ ¿NO AST RESULTS¿ ISSUES FOR MULTIPLE ANTIBIOTICS WITH KLEBSIELLA PNEUMONIAE IN ASSOCIATION WITH VITEK® REVEAL¿ SENSOR PANEL (20 TESTS) (REF. 900-00002, LOT. UNKNOWN) IT IS UNDERSTOOD THAT CONDENSATION ISSUES HAS BEEN A REOCCURRING PROBLEM FOR THIS CUSTOMER. IT IS VERY UNUSUAL TO HAVE SUCH A MASSIVE AMOUNT OF CONDENSATION IN THE BEGINNING OF THE RUN AND NONE BY THE END. BIOMÉRIEUX ENGINEER AND GLOBAL CUSTOMER SERVICE ARE THEORIZING THAT IF CUSTOMERS ARE SEALING A COLD SENSOR, IT CREATES A TEMPERATURE GRADIENT THAT WILL CAUSE THE CONDENSATION IN THE BEGINNING OF THE RUN. GCS ASKED THE FOLLOWING QUESTIONS TO LOCAL CUSTOMER SERVIC

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319365 ↗
• MalfunctionJun 24, 2025Unable to Obtain Readings; Appropriate Device Problem Term/Code Not Available; Unable to Obtain Readings; Appropriate Device Problem Term/Code Not Available

  INTENDED USE: THE REVEAL AST SYSTEM IS AN IN-VITRO DIAGNOSTIC (IVD) AUTOMATED SYSTEM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ORGANISMS DIRECT FROM POSITIVE BLOOD CULTURE. THE REVEAL AST ASSAYS ARE INDICATED FOR SUSCEPTIBILITY TESTING OF SPECIFIC PATHOGENIC BACTERIA COMMONLY ASSOCIATED WITH OR CAUSING BACTEREMIA AS WELL AS BACTERIAL ISOLATES FROM OTHER SPECIMEN TYPES. RESULTS ARE INTENDED TO BE USED IN CONJUNCTION WITH GRAM STAIN, ORGANISM IDENTIFICATION AND OTHER CLINICAL LABORATORY FINDINGS. ISSUE DESCRIPTION: A CUSTOMER IN SPAIN NOTIFIED BIOMÉRIEUX OF DISCORDANT RESULTS FOR ANTIBIOTICS : CEFTAZIDIME -POTENTIAL FALSE SUSCEPTIBLE RESULTS IN ASSOCIATION WITH VITEK® REVEAL¿ SENSOR PANEL (20 TESTS) (REF. 900-00002, LOT. 101724GWA). CUSTOMER REPORTED THAT WHEN COMPARING THE RESULTS OBTAINED WITH VITEK REVEAL AND MICRODILUTION THE CUSTOMER REPORTED DISCORDANT RESULTS. RESULTS ARE SUMMARIZED BELOW: (B)(4): THE LOT NUMBERS ARE 101724GWA FOR THE SENSOR AND (B)(6) 2025. ANTIBIOTIC CEFTAZIDIME REPORTED MIC 0.5 S WHILE IT WAS RESISTANT WITH DIFFUSION DISK. UNDER THE SUSPICION THAT THE VITEK REVEAL RESULTS WERE NOT CORRECT, THEY WERE NOT REPORTED AND THEREFORE DID NOT HAVE ANY EFFECT ON TH

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313490 ↗
• MalfunctionJun 23, 2025Unable to Obtain Readings; Appropriate Device Problem Term/Code Not Available; Unable to Obtain Readings; Appropriate Device Problem Term/Code Not Available

  INTENDED USE: THE REVEAL AST SYSTEM IS AN IN-VITRO DIAGNOSTIC (IVD) AUTOMATED SYSTEM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ORGANISMS DIRECT FROM POSITIVE BLOOD CULTURE. THE REVEAL AST ASSAYS ARE INDICATED FOR SUSCEPTIBILITY TESTING OF SPECIFIC PATHOGENIC BACTERIA COMMONLY ASSOCIATED WITH OR CAUSING BACTEREMIA AS WELL AS BACTERIAL ISOLATES FROM OTHER SPECIMEN TYPES. RESULTS ARE INTENDED TO BE USED IN CONJUNCTION WITH GRAM STAIN, ORGANISM IDENTIFICATION AND OTHER CLINICAL LABORATORY FINDINGS. ISSUE DESCRIPTION: A CUSTOMER IN SPAIN NOTIFIED BIOMÉRIEUX OF DISCORDANT RESULTS FOR ANTIBIOTICS : AMOXICILLIN -CLAVULANIC ACID , CEFTAZIDIME AND CEFTOLOZAZE- TAZOBACTAM IN ASSOCIATION WITH VITEK® REVEAL¿ SENSOR PANEL (20 TESTS) (REF. 900-00002, LOT. 101224GWA). CUSTOMER REPORTED THAT WHEN COMPARING THE RESULTS OBTAINED WITH VITEK REVEAL AND MICRODILUTION , RESULTS ARE DISCORDANT. RESULTS ARE SUMMARIZED BELOW: (B)(4). LOT NUMBERS ARE 101224GWA FOR THE SENSOR AND (B)(6) 2025 FOR THE PANEL AMOXICILLIN -CLAVULANIC ACID REPORTED R IN REVEAL AND S WITH MICRODILUTION CEFTAZIDIME REPORTED I IN REVEAL AND S WITH MICRODILUTION CEFTOLOZAZE- TAZOBACTAM REPORTED R IN REVEAL AND S WITH MICRODILUTION. U

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307162 ↗
• MalfunctionJun 23, 2025High Test Results; Appropriate Device Problem Term/Code Not Available; High Test Results; Appropriate Device Problem Term/Code Not Available

  INTENDED USE: THE REVEAL AST SYSTEM IS AN IN-VITRO DIAGNOSTIC (IVD) AUTOMATED SYSTEM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ORGANISMS DIRECT FROM POSITIVE BLOOD CULTURE. THE REVEAL AST ASSAYS ARE INDICATED FOR SUSCEPTIBILITY TESTING OF SPECIFIC PATHOGENIC BACTERIA COMMONLY ASSOCIATED WITH OR CAUSING BACTEREMIA AS WELL AS BACTERIAL ISOLATES FROM OTHER SPECIMEN TYPES. RESULTS ARE INTENDED TO BE USED IN CONJUNCTION WITH GRAM STAIN, ORGANISM IDENTIFICATION AND OTHER CLINICAL LABORATORY FINDINGS. ISSUE DESCRIPTION: A CUSTOMER IN SPAIN NOTIFIED BIOMÉRIEUX OF DISCORDANT RESULTS FOR CEFTAZIDIME-CLAVULANATE -POTENTIAL FALSE RESISTANT RESULTS IN ASSOCIATION WITH VITEK® REVEAL¿ SENSOR PANEL (20 TESTS) (REF. 900-00002, LOT. 101724GWA). CUSTOMER REPORTED THAT WHEN COMPARING THE RESULTS OBTAINED WITH VITEK REVEAL AND MICRODILUTION THE CUSTOMER REPORTED DISCORDANT RESULTS. RESULTS ARE SUMMARIZED BELOW: AST__20250530_1353__R205__A1__LF THE LOT NUMBERS ARE 101724GWA FOR THE SENSOR AND 2025-06-10 ANTIBIOTIC CEFTAZIDIME-CLAVULANATE REPORTED POSITIVE WHILE IT WAS SENSITIVE WITH DIFFUSION DISK. UNDER THE SUSPICION THAT THE VITEK REVEAL RESULTS WERE NOT CORRECT, THEY WERE NOT REPORTED AND THEREFORE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307144 ↗
• MalfunctionJun 23, 2025Unable to Obtain Readings; Appropriate Device Problem Term/Code Not Available; Unable to Obtain Readings; Appropriate Device Problem Term/Code Not Available

  INTENDED USE: THE REVEAL AST SYSTEM IS AN IN-VITRO DIAGNOSTIC (IVD) AUTOMATED SYSTEM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ORGANISMS DIRECT FROM POSITIVE BLOOD CULTURE. THE REVEAL AST ASSAYS ARE INDICATED FOR SUSCEPTIBILITY TESTING OF SPECIFIC PATHOGENIC BACTERIA COMMONLY ASSOCIATED WITH OR CAUSING BACTEREMIA AS WELL AS BACTERIAL ISOLATES FROM OTHER SPECIMEN TYPES. RESULTS ARE INTENDED TO BE USED IN CONJUNCTION WITH GRAM STAIN, ORGANISM IDENTIFICATION AND OTHER CLINICAL LABORATORY FINDINGS. ISSUE DESCRIPTION: A CUSTOMER IN SPAIN NOTIFIED BIOMÉRIEUX OF ¿NO AST RESULTS¿ ISSUES IN ASSOCIATION WITH VITEK® REVEAL¿ SENSOR PANEL (20 TESTS) (REF. 900-00002, LOT. 2025-06-10) RESULTS ARE SUMMARIZED BELOW: 1. AST__20250520_1311__R205__A1__LF THERE IS NO RESULT FOR THE ANTIBIOTICS AZTREONAM, CEFTOLOZANE -TAZOBACTAM AND IMIPENEM. THE SAMPLE IS BLOOD CULTURE THAT WAS PROCESSED WITHING THE NEXT 2 HOURS AFTER REPORTED POSITIVE. THE LOT NUMBERS ARE 101724GWA FOR THE SENSOR AND 2025-06-10 FOR THE PANEL AT THE TIME OF THE GLOBAL ASSESSMENT, BIOMÉRIEUX GLOBAL CUSTOMER SERVICE DID NOT GET THE DATA FROM THE CUSTOMER TO DETERMINE THE ROOT CAUSE OF THE ISSUE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307047 ↗
• MalfunctionMar 24, 2025Unable to Obtain Readings; Unable to Obtain Readings

  INTENDED USE: THE REVEAL AST SYSTEM IS AN IN-VITRO DIAGNOSTIC (IVD) AUTOMATED SYSTEM FOR ANTIMICROBIAL SUSCEPTIBILITY TESTING OF ORGANISMS DIRECT FROM POSITIVE BLOOD CULTURE. THE REVEAL AST ASSAYS ARE INDICATED FOR SUSCEPTIBILITY TESTING OF SPECIFIC PATHOGENIC BACTERIA COMMONLY ASSOCIATED WITH OR CAUSING BACTEREMIA AS WELL AS BACTERIAL ISOLATES FROM OTHER SPECIMEN TYPES. RESULTS ARE INTENDED TO BE USED IN CONJUNCTION WITH GRAM STAIN, ORGANISM IDENTIFICATION AND OTHER CLINICAL LABORATORY FINDINGS. ISSUE DESCRIPTION: A CUSTOMER IN ITALY NOTIFIED BIOMÉRIEUX OF ¿NO CALL¿ ISSUES IN ASSOCIATION WITH VITEK® REVEAL¿ SENSOR PANEL (20 TESTS) (REF. 900-00002, LOT UNKNOWN) THE CUSTOMER NOTIFIED ¿NO CALL¿ ISSUES FOR SEVERAL SAMPLES ANALYZED BY THE INSTRUMENT, REGARDING VARIOUS TYPES OF ORGANISMS. QUALITY CONTROLS ON THE NEW BATCH WERE PERFORMED AND PASSED SUCCESSFULLY. THE CUSTOMER INDICATED THAT IT IS HAPPENING FREQUENTLY BUT THAT IT IS NOT SPECIFIC TO A STRAIN-ANTIBIOTIC COMBINATION. FOR THE SAME COMBINATION, SOMETIMES THERE ARE NO CALLS OTHER TIMES THERE ARE. REMOTE ACCESS IS NOT AVAIABLE AT THIS CUSTOMER SITE. BIOMÉRIEUX GLOBAL CUSTOMER SERVICE HAS BEEN UNABLE TO OBTAIN THE DATA FROM THE CU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21675336 ↗