ePlex BCID-FP 12 Kit BoxRecalls & reported problems
Genmark Diagnostics, Inc. · ePlex Blood Culture Identification Fungal Pathogen (FP) 12-test kit box · Class 2
All models of ePlex (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00857167005290), received between Nov 26, 2024 and Jan 13, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “False Negative Result” (3 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.
Reports received per month
Most reported problems
Device problems
- False Negative Result3
- False Positive Result1
- Non Reproducible Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionNov 26, 2024False Negative Result; Non Reproducible Results; False Negative Result; Non Reproducible Results
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR TWO PATIENT SAMPLES USING THE EPLEX BLOOD CULTURE IDENTIFICATION FUNGAL PATHOGEN (BCID-FP) PANEL ON A EPLEX INSTRUMENT. SAMPLE 1 INITIALLY GENERATED NEGATIVE RESULTS, HOWEVER, MALDI IDENTIFICATION OF THE SUBCULTURE GROWTH WAS CANDIDA LUSITANIAE WITH LOG SCORE >2. ON (B)(6) 2024, SAMPLE 2 INITIALLY GENERATED A POSITIVE RESULT FOR THE CANDIDA PARAPSILOSIS TARGET. CULTURE DETECTED CANDIDA PARAPSILOSIS AND CANDIDA LUSITANIAE. THE MALDI LOG SCORE WAS >2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20783765 ↗
Other Fungal Organisms, Nucleic Acid-Based Assay devices
- ePlex BCID-GP 12 Kit BoxGenmark Diagnostics, Inc. · Fungal Organisms, Nucleic Acid-Based Assay1 death36 reports
- ePlex BCID-GN 12 Kit BoxGenmark Diagnostics, Inc. · Fungal Organisms, Nucleic Acid-Based Assay3 deaths19 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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