EPLEX BLOOD CULTURE IDENTIFICATION FUNGAL PATHOGEN (BCID-FP) PANEL
Received Jul 24, 2025 · Event occurred Jun 25, 2025
Report 3008632402-2025-02245 · MDR key 22586086
Device
Generic name
Fungal Organisms, Nucleic Acid-based Assay
Manufacturer
Genmark Diagnostics, Inc.Catalog number
09556516001
Lot number
10223348
Product problems
- False Negative Result
- False Positive Result
- False Negative Result
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS EPLEX CORE UNIT SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
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.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A SPECIFIC ROOT CAUSE.