ePlexRecalls & reported problems across all models

We found 3 models of ePlex by Genmark Diagnostics, Inc. in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Jul 9, 2021 and May 11, 2026 — classified as 4 deaths, 54 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (47 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. 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

Most reported ePlex problems

ePlex models

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

• ePlex BCID-GP 12 Kit Box

  Fungal Organisms, Nucleic Acid-Based Assay
  1 death36 reports
• ePlex BCID-GN 12 Kit Box

  Fungal Organisms, Nucleic Acid-Based Assay
  3 deaths19 reports
• ePlex BCID-FP 12 Kit Box

  Fungal Organisms, Nucleic Acid-Based Assay
  3 reports

Recent ePlex adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS WITH THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL FOR 8 PATIENT SAMPLES TESTED ON THE EPLEX ANALYZER. SAMPLE 1: THE EPLEX RESULTS WERE ENTEROCOCCUS, ENTEROCOCCUS FAECALIS, VANA; LISTERIA, LISTERIA MONOCYTOGENES, LACTOBACILLUSM AND PAN GRAM-NEGATIVE. THE CULTURE RESULTS WERE LEUCONOSTOC PSEUDOMESENTEROIDES. SAMPLE 2 ((B)(6) 2026): THE EPLEX RESULTS WERE ENTEROCOCCUS, ENTEROCOCCUS FAECALIS, LACTOBACILLUS, STAPHYLOCOCCUS, STAPHYLOCOCCUS AUREUS, MECA, AND VANA. THE CULTURE RESULTS WERE METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS. SAMPLE 3 ((B)(6) 2026): THE EPLEX RESULTS WERE ENTEROCOCCUS, ENTEROCOCCUS FAECALIS, LACTOBACILLUS, LISTERIA, LISTERIA MONOCYTOGENES, STAPHYLOCOCCUS, STREPTOCOCCUS, STREP AGALACTIAE, PAN GRAM-NEGATIVE, MECA, AND VANA. THE CULTURE RESULT WAS STAPHYLOCOCCUS HOMINIS. SAMPLE 4 ((B)(6) 2026): THE EPLEX RESULTS WERE ENTEROCOCCUS, ENTEROCOCCUS FAECALIS, LACTOBACILLUS, LISTERIA, LISTERIA MONOCYTOGENES, STREPTOCOCCUS, STREP AGALACTIAE, PAN GRAM-NEGATIVE, AND VANA. THE REPEAT EPLEX RESULT WAS STREPTOCOCCUS DETECTED. THE CULTURE RESULTS WERE STREPTOCOCCUS HALICHOERI (IDENTIFIED BY A REFERENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142445 ↗
• MalfunctionMar 9, 2026False Negative Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE RESULT WHILE USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON THE GM EPLEX BASE ANALYZER. THE EPLEX RESULT WAS STAPHYLOCOCCUS. THE CULTURE RESULT WAS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24550979 ↗
• MalfunctionMar 2, 2026Signal Artifact/Noise; False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL RESULT FROM THE GM EPLEX BASE ANALYZER. THE BCID-GN PANEL DETECTED ENTEROBACTER CLOACAE COMPLEX AND KLEBSIELLA PNEUMONIAE CARBAPENEMASE (KPC) TARGETS. THE CULTURE GREW ENTEROBACTER CLOACAE COMPLEX THAT WAS SENSITIVE TO ALL CEPHALOSPORINS TESTED AND ONLY RESISTANT TO AMOXICILLIN-CLAVULANIC ACID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489183 ↗
• MalfunctionJan 23, 2026False Negative Result; Unable to Obtain Readings

  THE INITIAL REPORTER STATED THEY RECEIVED FALSE NEGATIVE RESULTS FOR THREE PATIENT SAMPLES TESTED WITH THE EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL ON A COBAS EPLEX CORE UNIT. FOR THE FIRST SAMPLE, THE EPLEX DID NOT DETECT ANY TARGETS, INCLUDING KLEBSIELLA PNEUMONIAE AND CTX-M. A CONCURRENT CULTURE OF THE SAMPLE GREW ESBL KLEBSIELLA PNEUMONIAE. FOR THE SECOND SAMPLE, THE EPLEX DETECTED ESCHERICHIA COLI. THE CONCURRENT CULTURE GREW MICROCOCCUS LUTEUS. RAW DATA ANALYSIS CONFIRMED THAT THE PAN GRAM POSITIVE TARGET WAS NOT DETECTED. THE THIRD SAMPLE WAS TESTED ON (B)(6) 2025 AND THE EPLEX DID NOT DETECT ANY TARGETS. THE CONCURRENT CULTURE GREW ACINETOBACTER BAUMANNII COMPLEX. RAW DATA ANALYSIS CONFIRMED THAT THE ACINETOBACTER BAUMANNII COMPLEX TARGET WAS NOT DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167764 ↗
• MalfunctionJan 13, 2026False Negative Result

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR THREE PATIENT SAMPLES USING THE COBAS® EPLEX BLOOD CULTURE IDENTIFICATION GRAM-POSITIVE (BCID-GP) PANEL ON A EPLEX BASE. THE ALLEGED SAMPLES GENERATED A NEGATIVE RESULT FOR STAPHYLOCOCCUS AUREUS, VRE ENTEROCOCCUS FAECIUM, OR STAPHYLOCOCCUS LUGDUNENSIS. THE FOLLOWING CULTURE RESULTS WERE BELIEVED TO BE CORRECT: SAMPLE 1: MSSA METHICILLIN SUSCEPTIBLE STAPHYLOCOCCUS AUREUS. SAMPLE 2: VRE ENTEROCOCCUS FAECIUM. SAMPLE 3: STAPHYLOCOCCUS LUGDUNENSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24057126 ↗
• MalfunctionJan 13, 2026False Negative Result

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR THREE PATIENT SAMPLES USING THE COBAS® EPLEX BLOOD CULTURE IDENTIFICATION GRAM-NEGATIVE (BCID-GP) PANEL ON A EPLEX BASE. THE ALLEGED SAMPLES GENERATED A NEGATIVE RESULT FOR ACINETOBACTER BAUMANII. CULTURE RESULTS IDENTIFIED ACINETOBACTER BAUMANII.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056813 ↗
• MalfunctionJan 13, 2026False Negative Result

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR THREE PATIENT SAMPLES USING THE COBAS® EPLEX BLOOD CULTURE IDENTIFICATION FUNGAL PATHOGEN (BCID-GP) PANEL ON A EPLEX BASE. THE ALLEGED SAMPLES GENERATED NEGATIVE RESULTS FOR CANDIDA AURIS. THE CULTURE RESULTS IDENTIFIED CANDIDA AURIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24056811 ↗
• MalfunctionNov 14, 2025Signal Artifact/Noise; False Positive Result; Signal Artifact/Noise; False Positive Result

  THERE WAS AN ALLEGATION OF A QUESTIONABLE EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL RESULT FROM THE GM EPLEX BASE ANALYZER. THE INITIAL TEST DETECTED ESCHERICHIA COLI AND KLEBSIELLA PNEUMONIAE CARBAPENEMASE (KPC) TARGETS. THE TEST WAS REPEATED TWICE, AND ONLY THE ESCHERICHIA COLI TARGET WAS DETECTED. CULTURE GREW E. COLI (IDENTIFIED BY MALDI-TOF), AND BD PHOENIX AST TESTING WAS NEGATIVE FOR ANY CARBAPENEMASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556024 ↗
• MalfunctionSep 19, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE-POSITIVE RESULTS FROM THE EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL ON A COBAS EPLEX CORE UNIT FOR A SINGLE PATIENT SAMPLE. ON (B)(6) 2025, INITIAL RESULTS WERE BACTEROIDES FRAGILIS, ESCHERICHIA COLI, PAN GRAM-POSITIVE, CTX-M, IMP, AND OXA DETECTED. THE REPEAT TEST HAD ESCHERICHIA COLI DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095893 ↗
• MalfunctionAug 15, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE-POSITIVE RESULTS FROM THE EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL ON A COBAS EPLEX CORE UNIT. SAMPLE 1 INITIAL RESULTS WERE BACTEROIDES FRAGILIS, CRONOBACTER SAKAZAKII, K. PNEUMONIAE GROUP, STENOTROPHOMONAS MALTOPHILIA, PAN GRAM POSITIVE, IMP, AND OXA DETECTED. THE REPEAT TEST ON (B)(6) 2025 HAD K. PNEUMONIAE GROUP DETECTED. SAMPLE 2, ON (B)(6) 2025, INITIAL RESULTS WERE BACTEROIDES FRAGILIS, CRONOBACTER SAKAZAKII, ESCHERICHIA COLI, STENOTROPHOMONAS MALTOPHILIA, PAN GRAM POSITIVE, CTX-M, IMP, OXA DETECTED. THE REPEAT TEST HAD E. COLI DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22818970 ↗
• MalfunctionAug 1, 2025Leak/Splash; Leak/Splash

  THE INITIAL REPORTER ALLEGED THAT THERE WAS A SAMPLE LEAK WITHIN THE COBAS EPLEX ANALYZER AFTER RUNNING THE COBAS EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL. THE CUSTOMER REPORTED THAT AN ALLEGED POSITIVE SAMPLE FOR NEISSERIA MENINGITIDIS WAS LEAKED WITHIN A BAY OF THE ANALYZER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685465 ↗
• MalfunctionJul 24, 2025False Negative Result; False Positive Result; False Negative Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR THE EPLEX BLOOD CULTURE IDENTIFICATION FUNGAL PATHOGEN (BCID-FP) PANEL USING THE COBAS EPLEX CORE UNIT. SAMPLE 1 INITIAL RESULT WAS C. ALBICANS AND C. FAMATA. ON (B)(6) 2025, THE REPEAT RESULT WAS C. ALBICANS AND C. FAMATA. THE CULTURE RESULTS WERE C. ALBICANS AND C. DUBLINIENSIS SAMPLE 2 INITIAL RESULT WAS C. DUBLINIENSIS AND C. FAMATA. ON (B)(6) 2025, THE REPEAT RESULT WAS C. FAMATA. THE CULTURE RESULT WAS C. DUBLINIENSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586086 ↗
• MalfunctionJun 23, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS USING THE EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL FOR 1 PATIENT SAMPLE ON AN EPLEX SYSTEM. IT WAS REPORTED THAT THE KLEBSIELLA PNEUMONIAE GROUP AND SALMONELLA TARGETS WERE DETECTED IN THE (BCID-GN) PANEL. THE SALMONELLA TARGET WAS REPORTEDLY FALSE-POSITIVE. ON (B)(6) 2025, THE SAMPLE WAS REPEATED. THE REPEATED RESULTS SHOWED THAT THE KLEBSIELLA PNEUMONIAE GROUP WAS DETECTED, AND THE SALMONELLA TARGET WAS NOT DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309713 ↗
• MalfunctionJun 12, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL RESULTS FOR 1 PATIENT ON AN EPLEX SYSTEM. IT WAS REPORTED THAT THE STAPHYLOCOCCUS AUREUS TARGET WAS DETECTED IN CULTURE, BUT THE BCID-GP TEST RESULT WAS NEGATIVE FOR THE STAPHYLOCOCCUS AUREUS TARGET. THE STAPHYLOCOCCUS SPECIES WAS DETECTED. THE SAMPLE WAS REPEATED TWICE, ONCE ON (B)(6) 2025. THE STAPHYLOCOCCUS AND STAPHYLOCOCCUS AUREUS TARGETS WERE DETECTED BOTH TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197472 ↗
• MalfunctionMay 9, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS USING THE EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL FOR 1 PATIENT ON AN EPLEX SYSTEM. IT WAS REPORTED THAT THE SERRATIA MARCESCENS AND PSEUDOMONAS AERUGINOSA TARGETS WERE DETECTED IN CULTURE, BUT THE BCID-GN TEST RESULT WAS NEGATIVE FOR THE PSEUDOMONAS AERUGINOSA TARGET. REPEAT TESTING WAS NOT PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993036 ↗