Simplexa™ Flu A/B & RSV Direct Gen II MOL2655Recalls & reported problems

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

Jan 30, 2023Open, Classified
Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error codes.
Z-1210-2023 · Root cause: Device Design · Recall details · FDA record ↗

Device details

UDI-DI	`20816101026962`
Brand	Simplexa™ Flu A/B & RSV Direct Gen II
Model	MOL2655
Company	Diasorin Molecular LLC
Product code	OCC · Respiratory Virus Panel Nucleic Acid Assay System
Class	Class 2
FDA submission	K201505
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	Jul 8, 2024

Device type (GMDN): Multiple-genus respiratory 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 multiple virus genera associated with respiratory diseases in a clinical specimen, using a nucleic acid technique (NAT). Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses. This test is commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Other Respiratory Virus Panel Nucleic Acid Assay System devices

ID NOW RSV 435-000
Alere Scarborough, Inc. · Respiratory Virus Panel Nucleic Acid Assay System
2 recalls0 reports
Panther Fusion® AMR KIT, PANTHER FUSION, 96T, IVD
Hologic, Inc. · Respiratory virus panel nucleic acid assay system
2 reports
Alere™ i Influenza A & B 425-024
Alere Scarborough, Inc. · Respiratory Virus Panel Nucleic Acid Assay System
1 death1 report

All Respiratory Virus Panel Nucleic Acid Assay System 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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
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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