ePlex BCID-GP 12 Kit BoxRecalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00857167005320), received between Dec 1, 2022 and May 11, 2026 — classified as 1 death, 35 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (34 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 25 most recent of 36 reports, 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 ↗
• 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 ↗
• 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 1, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF FALSE NEGATIVE STAPHYLOCOCCUS AND MECA RESISTANCE GENE RESULTS WHILE USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON A GM EPLEX BASE ANALYZER. THE RESULT FOR THE INITIAL TEST WAS NO TARGETS DETECTED. THE CULTURE RESULT FOR THIS SAMPLE WAS STAPHYLOCOCCUS HAEMOLYTICUS. ON (B)(6) 2025, THE SAMPLE WAS RETESTED ON THE EPLEX AND RESULTED IN THE DETECTION OF STAPHYLOCOCCUS SPECIES AND MECA RESISTANCE GENE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942583 ↗
• MalfunctionApr 24, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF A FALSE NEGATIVE ENTEROCOCCUS FAECALIS RESULT FROM THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON A GM EPLEX BASE ANALYZER. THE INITIAL TESTING DETECTED ONLY ENTEROCOCCUS. THE CULTURE RESULT WAS ENTEROCOCCUS FAECALIS. THE MALDI-TOF RESULT WAS 99%.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900813 ↗
• MalfunctionApr 24, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF FALSE NEGATIVE STAPHYLOCOCCUS AND MEC A RESISTANCE GENE RESULTS FROM THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON A GM EPLEX BASE ANALYZER. THE INITIAL TESTING RESULTED IN THE DETECTION OF PAN GRAM-NEGATIVE ONLY. THE SAMPLE WAS THEN RETESTED ON THE EPLEX AND RESULTED IN THE DETECTION OF STAPHYLOCOCCUS SPECIES AND PAN-GRAM-NEGATIVE. THE CULTURE FOR THE SAMPLE RESULTED IN SERRATIA MARCESCENS, COAGULASE-NEGATIVE STAPHYLOCOCCUS, AND OXACILLIN RESISTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900774 ↗
• MalfunctionApr 24, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF FALSE NEGATIVE RESULTS FROM THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ASSAY ON A GM EPLEX BASE ANALYZER. THE RESULT OF THE INITIAL TEST WAS STAPHYLOCOCCUS ONLY. THE CULTURE RESULT FOR THIS SAMPLE WAS STAPHYLOCOCCUS AUREUS. THE SAMPLE WAS RETESTED ON THE EPLEX ON (B)(6) 2025 AND RESULTED IN THE DETECTION OF STAPHYLOCOCCUS AND STAPHYLOCOCCUS AUREUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900086 ↗
• MalfunctionApr 4, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL FOR 1 PATIENT SAMPLE ON AN EPLEX SYSTEM. IT WAS REPORTED THAT THE STAPHYLOCOCCUS EPIDERMIDIS TARGET WAS DETECTED IN CULTURE, BUT THE BCID-GP TEST RESULT WAS NEGATIVE FOR THE STAPHYLOCOCCUS EPIDERMIDIS TARGET. THE SAMPLE WAS RECEIVED FOR INVESTIGATION. DURING THE INVESTIGATION, THE BCID-GP TEST RESULT WAS NEGATIVE FOR THE MECA AND STAPHYLOCOCCUS GENUS TARGETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777455 ↗
• MalfunctionApr 2, 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 AND WITH A COMPETITOR METHOD (MALDI), BUT THE BCID-GP TEST RESULT WAS NEGATIVE FOR THE STAPHYLOCOCCUS AUREUS TARGET. ONLY THE STAPHYLOCOCCUS TARGET WAS DETECTED WHEN USING THE BCID-GP TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751944 ↗
• MalfunctionMar 28, 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. NO REPEAT TESTING WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721891 ↗
• MalfunctionMar 28, 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 SAMPLE WAS REPEATED ON (B)(6) 2025 ON THE EPLEX SYSTEM. THE STAPHYLOCOCCUS AUREUS TARGET WAS DETECTED, BUT THE BCID-GP TEST RESULT WAS NEGATIVE FOR THE STAPHYLOCOCCUS AUREUS TARGET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719353 ↗
• MalfunctionMar 28, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF FALSE NEGATIVE PAN GRAM NEGATIVE RESULTS USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON AN EPLEX BASE ANALYZER. THE INITIAL TESTING FOR THE GRAM-POSITIVE PANEL (INCLUDING THE PAN GRAM-NEGATIVE TARGET) WAS NEGATIVE. THE GRAM-NEGATIVE PANEL DETECTED FUSOBACTERIUM NUCLEATUM. THE CULTURE RESULT WAS MICROCOCCUS LUTEUS AND FUSOBACTERIUM NUCLEATUM. ON (B)(6) 2025, THE REPEAT TEST OF THE GRAM-POSITIVE PANEL (INCLUDING THE PAN GRAM-NEGATIVE TARGET) WAS NEGATIVE. THE CULTURE RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718593 ↗
• MalfunctionMar 27, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF A FALSE NEGATIVE STAPHYLOCOCCUS AUREUS RESULT USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL, GRAM POSITIVE (BCID-GP) PANEL ON AN EPLEX BASE ANALYZER. THE INITIAL TESTING DETECTED ONLY STREPTOCOCCUS AGALACTIAE. THE BLOOD CULTURE RESULTS WERE STAPHYLOCOCCUS AUREUS AND STREPTOCOCCUS AGALACTIAE. ON (B)(6) 2025, THE REPEAT TEST ON THE EPLEX DETECTED BOTH STAPHYLOCOCCUS AUREUS AND STREPTOCOCCUS AGALACTIAE. THE CULTURE RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707721 ↗
• MalfunctionMar 24, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF FALSE NEGATIVE ENTEROCOCCUS FAECALIS AND FALSE NEGATIVE PAN GRAM NEGATIVE RESULTS FOR TWO SAMPLES USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON AN EPLEX BASE ANALYZER. THE EPLEX RESULT WAS STREPTOCOCCUS PYOGENES DETECTED. THE CULTURE RESULTS WERE STREPTOCOCCUS PYOGENES, ENTEROCOCCUS FAECALIS, AND ESCHERICHIA COLI. THE MALDI RESULTS STREPTOCOCCUS PYOGENES AND ENTEROCOCCUS FAECALIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679412 ↗
• MalfunctionMar 21, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF FALSE NEGATIVE STAPHYLOCOCCUS AUREUS RESULTS FOR TWO SAMPLES FROM THE SAME PATIENT USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL RESULTS WITH THE EPLEX BASE UNITS. THE SAMPLES WERE FROM THE SAME PATIENT BUT DIFFERENT BOTTLE SETS. THE TESTS WERE PERFORMED ON (B)(6) 2025. SAMPLE 1 WAS TESTED ON ANALYZER EPLEX SERIAL NUMBER (B)(6) MULTIPLE TIMES AND THEN TESTED ON EPLEX SERIAL NUMBER (B)(6). SAMPLE 2 WAS ONLY TESTED ON EPLEX SERIAL NUMBER (B)(6). ALL OF THE RESULTS FROM THE EPLEX ANALYZERS WERE STAPHYLOCOCCUS SPECIES. THE CULTURE RESULTS WERE STAPHYLOCOCCUS AUREUS (MSSA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662205 ↗
• MalfunctionMar 20, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL FOR 1 PATIENT SAMPLE ON AN EPLEX SYSTEM. IT WAS REPORTED THAT ENTEROCOCCUS FAECALIS WAS DETECTED IN CULTURE AND THE BCID-GP TEST RESULT WAS NEGATIVE. NO REPEAT TESTING WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652905 ↗
• MalfunctionMar 20, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF FALSE NEGATIVE STAPHYLOCOCCUS AUREUS RESULTS FOR THREE PATIENT SAMPLES USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON THE EPLEX BASE ANALYZER. SAMPLE 1: ON (B)(6) 2025, RESULT WAS STAPHYLOCOCCUS. ON (B)(6) 2025, THE REPEAT RESULT WAS STAPHYLOCOCCUS AND STAPHYLOCOCCUS AUREUS. THE CULTURE RESULT WAS STAPHYLOCOCCUS AUREUS (MSSA). SAMPLE 2: ON (B)(6) 2025, RESULT WAS STAPHYLOCOCCUS, ENTEROCOCCUS, AND ENTEROCOCCUS FAECALIS. ON (B)(6) 2025, THE REPEAT RESULT WAS STAPHYLOCOCCUS, ENTEROCOCCUS, AND ENTEROCOCCUS FAECALIS. THE CULTURE RESULT WAS STAPHYLOCOCCUS AUREUS (MSSA) AND ENTEROCOCCUS FAECALIS. SAMPLE 3: ON (B)(6) 2025, RESULT WAS STAPHYLOCOCCUS AND PAN GRAM-NEGATIVE. THE CULTURE RESULT WAS STAPHYLOCOCCUS AUREUS (MSSA), E. COLI, AND K. PNEUMONIAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651368 ↗
• MalfunctionMar 18, 2025False Positive Result; False Positive Result

  THERE WAS AN ALLEGATION OF FALSE NEGATIVE STAPHYLOCOCCUS AUREUS RESULTS FOR TWO PATIENT SAMPLES USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON A COBAS EPLEX CORE UNIT. THE INITIAL RESULT FOR BOTH SAMPLES WAS "NO TARGETS DETECTED". FOR SAMPLE 1, A REPEAT TEST DETECTED STAPHYLOCOCCUS GENUS, STAPHYLOCOCCUS AUREUS, AND MECA. THE CULTURES FOR EACH SAMPLE GREW STAPHYLOCOCCUS AUREUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21630894 ↗
• MalfunctionMar 17, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF FALSE NEGATIVE STAPHYLOCOCCUS AND MECA RESULTS USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON THE EPLEX BASE ANALYZER. THE INITIAL EPLEX RESULTS WERE "NO TARGETS DETECTED". THE REPEAT RESULTS FROM THE EPLEX WERE STAPHYLOCOCCUS AND MECA DETECTED. THE CULTURE RESULT CONFIRMED STAPHYLOCOCCUS HAEMOLYTICUS. THE CULTURE RESULT WAS REPORTED TO THE ORDERING PROVIDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617855 ↗
• MalfunctionMar 6, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF A FALSE NEGATIVE RESULT FOR STAPHYLOCOCCUS AUREUS USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON AN EPLEX BASE. THE EPLEX DETECTED STAPHYLOCOCCUS BUT DID NOT DETECT STAPHYLOCOCCUS AUREUS. THE CULTURE RECOVERED STAPHYLOCOCCUS (MSSA-METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21539252 ↗
• MalfunctionMar 6, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF FALSE NEGATIVE ENTEROCOCCUS AND ENTEROCOCCUS FAECALI RESULTS FOR ONE BLOOD CULTURE SAMPLE USING THE COBAS® EPLEX BLOOD CULTURE IDENTIFICATION GRAM-POSITIVE PANEL (BCID-GP) ASSAY ON A GM EPLEX BASE ANALYZER. THE GRAM STAIN RESULT WAS GRAM POSITIVE COCCI IN PAIR/CHAINS AND GRAM-NEGATIVE RODS. THE CULTURE RESULTS WERE E. COLI, P. MIRABILIS, AND ENTEROCOCCUS FAECALIS. THERE WAS NO VANCOMYCIN-RESISTANT ENTEROCOCCI (VRE). FROM THE EPLEX, THE PAN GRAM-NEGATIVE RESULT WAS POSITIVE AND THE ENTEROCOCCUS AND E. FAECALIS RESULTS WERE "NOT DETECTED". THE SAME SAMPLE WAS REPEATED ON (B)(6) 2025 AND SHOWED THE EXPECTED RESULTS OF PAN GRAM-NEGATIVE AND ENTEROCOCCUS AND E. FAECALIS WERE ALL "DETECTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535374 ↗
• MalfunctionMar 3, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL FOR 1 PATIENT ON AN EPLEX SYSTEM. IT WAS REPORTED THAT PROTEUS MIRABILIS WAS DETECTED IN CULTURE, AND THE BCID-GP TEST RESULT FOR PAN GRAM NEGATIVE WAS NEGATIVE. THE SAMPLE WAS REPEATED, AND THE BCID-GP TEST RESULT FOR PAN GRAM NEGATIVE WAS NEGATIVE. TWO BLOOD CULTURE BOTTLES WERE TESTED FOR THIS PATIENT (1 ANAEROBIC AND 1 AEROBIC). THE ANAEROBIC BOTTLE WAS TESTED, AND NO TARGETS WERE DETECTED. THE AEROBIC BOTTLE WAS TESTED AND STAPHYLOCOCCUS AND MECA TARGETS WERE DETECTED AND THAT WERE CONFIRMED IN THE CULTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21505175 ↗
• MalfunctionFeb 20, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF A FALSE NEGATIVE STAPHYLOCOCCUS AUREUS RESULT FROM A POSITIVE BLOOD CULTURE USING THE GM EPLEX BASE ANALYZER. THE EPLEX SHOWED A STRONG SIGNAL FOR THE STAPHYLOCOCCUS TARGET. THE STAPHYLOCOCCUS AUREUS TARGET RESULT WAS BELOW THE THRESHOLD OF THE ASSAY. THE POSITIVE RESULT FOR STAPHYLOCOCCUS AUREUS WAS CONFIRMED USING CULTURES AND MASS SPECTROMETRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421372 ↗
• MalfunctionFeb 12, 2025False Negative Result; False Negative Result

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR FOUR PATIENT SAMPLES USING THE COBAS® EPLEX BLOOD CULTURE IDENTIFICATION GRAM-POSITIVE (BCID-GP) PANEL ON A EPLEX BASE. THE FIRST ALLEGED SAMPLE GENERATED A NOT DETECTED RESULT FOR STAPHYLOCOCCUS, STAPHYLOCOCCUS EPIDERMIDIS, AND MECA TARGETS. THE SAMPLE WAS REPEATED AND GENERATED A POSITIVE RESULT FOR STAPHYLOCOCCUS, STAPHYLOCOCCUS EPIDERMIDIS, AND MECA TARGETS. THE SECOND ALLEGED SAMPLE GENERATED A NOT DETECTED RESULT FOR STAPHYLOCOCCUS. THE SAMPLE WAS REPEATED AND A GENERATED A POSITIVE RESULT FOR STAPHYLOCOCCUS. THE THIRD ALLEGED SAMPLE GENERATED A NOT DETECTED RESULT FOR STAPHYLOCOCCUS, STAPHYLOCOCCUS EPIDERMIDIS, AND MECA TARGETS. THE SAMPLE WAS REPEATED AND GENERATED A POSITIVE RESULT FOR STAPHYLOCOCCUS, STAPHYLOCOCCUS EPIDERMIDIS, AND MECA TARGETS. THE FOURTH ALLEGED SAMPLE GENERATED A NOT DETECTED RESULT FOR ENTEROCOCCUS AND ENTEROCOCCUS FAECALIS. THE SAMPLE WAS REPEATED AND GENERATED A POSITIVE RESULT FOR ENTEROCOCCUS AND ENTEROCOCCUS FAECALIS TARGETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363267 ↗