ePlex BCID-GN 12 Kit BoxRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00857167005313), received between Jul 9, 2021 and Mar 2, 2026 — classified as 3 deaths, 16 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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-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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 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 ON AN EPLEX SYSTEM. THE SAMPLE WAS REPORTED AS REACTIVE FOR BOTH ESCHERICHIA COLI AND THE NDM RESISTANCE GENE. SUBSEQUENT SUSCEPTIBILITY TESTING ON 30-MAR-2025 DID NOT CORRELATE WITH THE EPLEX RESULT. ON 30-MAR-2025, THE SAMPLE WAS RETESTED FOUR TIMES, AND ESCHERICHIA COLI WAS DETECTED, BUT THE NDM RESISTANCE GENE WAS NOT DETECTED. THE CULTURE AND SUSCEPTIBILITY TESTS MATCHED THE REPEATED EPLEX RESULTS THAT INDICATED THE ABSENCE OF THE NDM RESISTANCE GENE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892560 ↗
• MalfunctionMar 21, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF FALSE NEGATIVE KLEBSIELLA OXYTOCA RESULTS FOR ONE PATIENT USING THE EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL ON EPLEX BASE ANALYZERS. THE INITIAL TEST FOR THE SAMPLE USING EPLEX BASE ANALYZER SERIAL NUMBER: (B)(6) DETECTED ONLY SERRATIA MARCESCENS. ON (B)(6) 2025, THE SAMPLE WAS REPEATED TWO TIMES USING EPLEX BASE ANALYZER SERIAL NUMBER: (B)(6) AND THE RESULTS WERE THE SAME. THE CULTURE RESULTS WERE SERRATIA MARCESCENS AND KLEBSIELLA OXYTOCA. USING MALDI-TOF TESTING, KLEBSIELLA OXYTOCA WAS IDENTIFIED. THE ORGANISM WAS NOT IDENTIFIED DURING BIOFIRE COMPARATOR TESTING. SERRATIA MARCESCENS WAS REPORTED OUT INITIALLY. THE KLEBSIELLA OXYTOCA RESULT WAS NOT REPORTED UNTIL AFTER THE CULTURE RESULT WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662208 ↗
• MalfunctionNov 22, 2024False Negative Result; False Negative Result

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) AND WITH THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON A GM EPLEX BASE SYSTEM. THIS MEDWATCH WILL APPLY TO THE BCID-GN PANEL. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE BCID-GP PANEL. WHEN THE SAMPLE WAS TESTED WITH THE BCID-GN PANEL ON (B)(6) 2024, IT RESULTED IN THE DETECTION OF ESCHERICHIA COLI ONLY. WHEN THE SAMPLE WAS TESTED WITH THE BCID-GP PANEL ON (B)(6) 2024, IT RESULTED IN THE DETECTION OF PAN-GRAM NEGATIVE ONLY. A CONCURRENT CULTURE OF THE SAMPLE IDENTIFIED EXTENDED-SPECTRUM BETA-LACTAMASE (ESBL) ESCHERICHIA COLI AND ENTEROCOCCUS FAECALIS. THE SAMPLE WAS CULTURED IN AN ANAEROBIC BOTTLE AND PLATED BY "WASP" PLACED IN CO2 AT 37 DEGREES CELCIUS AND A BRUCELLA PLATE IN ANAEROBIC CONDITIONS AT 37 DEGREES CELCIUS. THERE WAS GROWTH OF ESCHERICHIA COLI ON A BLOOD AGAR PLATE, A CHOCOLATE PLATE, A MACCONKEY PLATE, AND A BRUCELLA PLATE. THERE WAS GROWTH OF ENTEROCOCCUS FAECALIS ON A BLOOD AGAR PLATE, A CHOCOLATE PLATE, A COLUMBIA NALIDIXIC ACI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20760276 ↗
• MalfunctionOct 31, 2024False Negative Result; Manufacturing, Packaging or Shipping Problem; False Negative Result; Manufacturing, Packaging or Shipping Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS USING THE EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL WITH ONE PATIENT SAMPLE ON A COBAS EPLEX INSTRUMENT. THE ALLEGED SAMPLE GENERATED A POSITIVE RESULT FOR THE ENTEROBACTER CLOACAE TARGET. THE CUSTOMER REPORTED THAT ENTEROBACTER CLOACAE AND SERRATIA MARCESCENS WERE DETECTED IN CULTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577743 ↗
• MalfunctionOct 31, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL RESULT FROM THE GM EPLEX BASE CU ANALYZER. NO TARGETS WERE DETECTED BY THE EPLEX, BUT A CULTURE GREW KLEBSIELLA OXYTOCA THAT WAS IDENTIFIED BY VITEK MS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577582 ↗
• MalfunctionOct 3, 2024False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS USING THE COBAS EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE PANEL WITH ONE PATIENT SAMPLE ON A COBAS EPLEX INSTRUMENT. THE ALLEGED SAMPLE GENERATED A NEGATIVE RESULT FOR ALL TARGETS. THE CUSTOMER REPORTED THAT KLEBSIELLA PNEUMONIAE WAS DETECTED IN CULTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362314 ↗
• MalfunctionOct 1, 2024False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS USING THE COBAS® EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE PANEL FOR ONE PATIENT SAMPLE ON A COBAS EPLEX SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED A NEGATIVE RESULT FOR ALL TARGETS. ON (B)(6) 2024, THE SAME SAMPLE WAS USED FOR THE REPEAT TESTING WHICH RESULTED IN A NEGATIVE RESULT FOR ALL TARGETS. THE CUSTOMER REPORTED THAT ESCHERICHIA COLI WAS DETECTED IN CULTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344044 ↗
• DeathOct 12, 2022False Positive Result; False Positive Result

  ON (B)(6) 2022, GENMARK WAS ADVISED OF DISCREPANT RESULTS ASSOCIATED WITH THE EPLEX BCID-GN PANEL TESTED ON (B)(6) 2022. THE EPLEX RESULT FOR THE SAMPLE IN QUESTION REPORTED DETECTION OF CITROBACTER, ENTEROBACTER CLOACAE COMPLEX, KLEBSIELLA PNEUMONIAE GROUP, WHERE THE CITROBACTER RESULT WAS CONSIDERED UNEXPECTED POSITIVE. CULTURE FOR THE SAME SAMPLE RESULTED IN IDENTIFICATION OF ENTEROBACTER CLOACAE COMPLEX, KLEBSEIELLA PNEUMONIAE AND STREPTOCOCCUS MITIS. ALTHOUGH NOT REPORTED AS AN UNEXPECTED RESULT BY THE CUSTOMER, GENMARK IS INVESTIGATING AN UNEXPECTED NEGATIVE RESULT FOR THE EPLEX BCID-GN PAN-GRAM POSITIVE RESULT SINCE STREPTOCOCCUS MITIS IS INCLUDED IN THIS RESULT. ON (B)(6) 2022, GENMARK WAS ADVISED THE PATIENT ASSOCIATED WITH THESE RESULTS IS DECEASED. GENMARK WAS ADVISED THE EPLEX BCID-GN RESULTS INCLUDING THE UNEXPECTED POSITIVE CITROBACTER RESULT WERE REPORTED TO THE PHYSICIAN, ALTHOUGH WHEN AVAILABLE THE CULTURE RESULTS WERE DEEMED TO BE CORRECT. GENMARK MADE MULTIPLE ATTEMPTS TO ACQUIRE ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT INCLUDING ASSOCIATION OF THE EPLEX RESULT TO THE PATIENT OUTCOME, HOWEVER ON (B)(6) 2022, THE CUSTOMER INDICATED THAT THEY WOULD NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591562 ↗
• DeathAug 30, 2022False Negative Result; False Negative Result

  ON (B)(6) 2022, GENMARK WAS ADVISED OF UNEXPECTED NEGATIVE RESULTS FOR PSEUDOMONAS AERUGINOSA ON THE EPLEX BCID-GN PANEL TESTED ON (B)(6) 2022. ON (B)(6) 2022, DURING COMMUNICATION RELATED TO THE INVESTIGATION GENMARK WAS ADVISED THAT PATIENT WAS DECEASED. THE CUSTOMER WAS NOT ABLE TO CONFIRM WHETHER THE RESULT OF THE EPLEX CONTRIBUTED TO THE DEATH OF THE PATIENT AND REFERRED TO THE PATIENT HISTORY OF LIVER FAILURE AND PREVIOUS ADMISSIONS FOR PSEUDOMONAS CHOLANGITIS/SEPSIS. GENMARK WAS ADVISED THAT THE PATIENT HAD BEEN ON 2 GRAMS OF IV MEROPENEM EVERY 12 HOURS FOR TWO WEEKS PRIOR TO BEING ADMISSION ON (B)(6) 2022 WITH WEAKNESS, FEVERS, AND CHILLS. BACKGROUND: AN INITIAL SET OF BLOOD CULTURE BOTTLES COLLECTED ON (B)(6) 2022 WAS NOT TESTED ON EPLEX AND SHOWED ONLY STENOTROPHOMONAS GROWING IN CULTURE. A SECOND SET OF BLOOD CULTURE BOTTLES WERE COLLECTED ON (B)(6) 2022 AND THIS TIME STENOTROPHOMONAS AND PSEUDOMONAS WERE SEEN IN CULTURE. AN ALIQUOT FROM THIS SET OF BLOOD CULTURE BOTTLES WAS TESTED WITH THE EPLEX BCID-GN ON (B)(6) 2022 WHERE ONLY STENOTROPHOMONAS MALTOPHILIA WAS DETECTED. TESTING A SECOND ALIQUOT FROM THE SAME BOTTLE WITH THE EPLEX BCID-GN AGAIN RESULTED IN ONLY STENOTRO

  Patient problems: Bacterial Infection

  MAUDE report 15324287 ↗
• DeathJul 9, 2021False Negative Result; False Negative Result

  MDR SUMMARY: WHILE GENMARK'S FIELD SERVICE AGENT WAS ON-SITE CONDUCTING ROUTINE PREVENTIVE MAINTENANCE ON THE EPLEX INSTRUMENT AT (B)(6) HOSPITAL, THE CUSTOMER INQUIRED A SPECIFIC DISCREPANT SAMPLE RESULT. THE EPLEX BCID-GN RESULTS REPORTS NO TARGETS WERE DETECTED, WHILE ANOTHER STANDARD OF CARE TEST METHOD (MALDI-TOF) REPORTED KLEBSIELLA OXYTOCA OR RAOULTELLA ORNITHINOLYTICA. KLEBSIELLA OXYTOCA IS AN ON-PANEL ORGANISM FOR THE EPLEX BCID-GN PANEL. RAOULTELLA ORNITHINOLYTICA IS AN OFF-PANEL ORGANISM FOR THE EPLEX BCID-GN PANEL THE CUSTOMER DID NOT SPECIFICALLY NOTIFY GENMARK OF A PATIENT DEATH, HOWEVER THEY PROVIDED PATIENT RECORDS ASSOCIATED WITH THE TEST RESULT AND IT WAS NOTED BY A GENMARK EMPLOYEE THAT THE RECORDS INDICATE THE PATIENT PASSED AWAY. RAW DATA ANALYSIS SHOWS THE REPORTED ACCESSION (B)(6) (MEASURED ON MAY (B)(6) 2021) IS NEGATIVE FOR ALL TARGETS WITH GOOD INTERNAL CONTROL SIGNALS. PER THE PATIENT RECORDS PROVIDED, PATIENT DEATH WAS (B)(6) 2021. GENMARK WAS MADE AWARE ON JUNE 11, 2021. ANALYSIS: REVIEW OF THE FOLLOWING INFORMATION SUGGESTS THAT THE EPLEX BCID-GN PANEL PERFORMED AS INTENDED AND WITHIN SPECIFICATION: QC RELEASE DATA FOR BCID-GN PANEL LOT 53930533 WAS RE

  Patient problems: Insufficient Information

  MAUDE report 12144354 ↗