cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System 08160104190Recalls & reported problems

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00875197005950), received between Nov 4, 2022 and Oct 30, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “False Positive 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 Positive Result1
Non Reproducible Results1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 30, 2024False Positive Result; False Positive Result
THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR A SINGLE PATIENT SAMPLE TESTED ON THE COBAS® INFLUENZA A/B & RSV NUCLEIC ACID TEST FOR USE ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE RESULT ON THE COBAS® LIAT ANALYZER. THE RETESTED SAMPLE GENERATED A NEGATIVE RESULT ON A DIFFERENT INSTRUMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20569037 ↗
MalfunctionNov 4, 2022Non Reproducible Results; Non Reproducible Results
A CUSTOMER FROM CHILE ALLEGED DISCREPANT RESULTS FOR A SINGLE PATIENT WHILE USING THE COBAS® INFLUENZA A/B & RSV NUCLEIC ACID TEST ON THE COBAS® LIAT® SYSTEM. THE ALLEGED SAMPLE INITIALLY GENERATED A POSITIVE RESULT FOR INFLUENZA A. THE SAME SAMPLE WAS RETESTED ON A DIFFERENT COBAS LIAT WHICH GENERATED A NEGATIVE RESULT FOR ALL TARGETS. THE SAME SAMPLE WAS ALSO RETESTED ON ANOTHER PLATFORM (ABBOTT) WHICH GENERATED A NEGATIVE RESULT FOR INFLUENZA A AND A POSITIVE RESULT FOR THE RSV TARGET. THE RESULTS WERE RELEASED. NO HARM WAS ALLEGED. AN INVESTIGATION WAS CONDUCTED TO EVALUATE THE CUSTOMER ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15728471 ↗

Device details

UDI-DI	`00875197005950`
Brand	cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System
Model	08160104190
Company	Roche Molecular Systems, Inc.
Product code	OZE · Influenza A And Influenza B Multiplex Nucleic Acid Assay
Class	Class 2
FDA submission	None listed
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	Nov 10, 2021

Device type (GMDN): Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from influenza A virus and/or influenza B virus in a clinical specimen, using a nucleic acid technique (NAT).

Other Influenza A And Influenza B Multiplex Nucleic Acid Assay devices

ARIES® Flu A/B & RSV Assay 50-10020
Luminex Corporation · Influenza A and influenza B multiplex nucleic acid assay
2 deaths2 reports

All Influenza A And Influenza B Multiplex Nucleic Acid Assay devices →

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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