ePlex System ePlex Respiratory Panel (RP)Recalls & reported problems

Genmark Diagnostics, Inc. · ePlex Respiratory Panel Kit, 12 test, IVD · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00857167005030), received between Mar 27, 2025 and Mar 27, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “False Negative Result” (1 report).

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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

False Negative Result1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 27, 2025False Negative Result; False Negative Result
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS USING THE EPLEX® RESPIRATORY PATHOGEN (RP) PANEL FOR 1 PATIENT SAMPLE ON AN EPLEX SYSTEM. THE PATIENT SAMPLE WAS TESTED 3 TIMES. IT WAS REPORTED THAT INFLUENZA A H3 WAS DETECTED DURING THE FIRST TEST, AND THERE WAS NO SIGNAL FOUND FOR THE INFLUENZA A TARGET. IT WAS REPORTED THAT FOR THE SECOND AND THIRD TESTS, NO INFLUENZA TARGETS WERE DETECTED EITHER TIME AND NO SIGNAL WAS IDENTIFIED IN THE DATA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21707932 ↗

Device details

UDI-DI	`00857167005030`
Brand	ePlex System
Model	ePlex Respiratory Panel (RP)
Catalog no.	EA001012
Company	Genmark Diagnostics, Inc.
Product code	OZY · Chlamydophila Pneumoniae Dna Assay System
Class	Class 2
FDA submission	K163636
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 18, 2023

Device type (GMDN): Multiple-genus respiratory virus antigen IVD, kit, multiplex

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen, using a multiplex method. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.

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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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