BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests 423883Recalls & reported problems
Biofire Diagnostics, LLC · IVD reagent kit containing 30 tests. · Class N
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815381020239), received between Jan 21, 2021 and Jan 21, 2021 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Inflammation1
- Pneumonia1
- Urinary Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUMMARY: (B)(6) REPORTED TWO POTENTIAL FALSE NEGATIVE SARS-COV-2 RESULTS ON THE BIOFIRE RESPIRATORY PANEL 2.1-EZ (RP2.1-EZ) (EUA) DURING PATIENT TESTING. THE CUSTOMER ALLEGED THAT DUE TO THE BIOFIRE RP2.1-EZ RESULTS, APPROPRIATE CARE WAS DELAYED AND THE PATIENT EXPERIENCED MULTISYSTEM FAILURE. UPON INVESTIGATION, NO MALFUNCTION OCCURRED AND THE SYSTEM WAS WORKING WITHIN SPECIFICATION. THE INVESTIGATION CONCLUDED THAT THERE IS LIKELY NO ERROR WITH THE BIOFIRE RP2.1-EZ RESULTS, HOWEVER BIOFIRE IS REPORTING OUT OF AN ABUNDANCE OF CAUTION BECAUSE THE CUSTOMER HAS ALLEGED PATIENT HARM.
Patient problems: Inflammation; Pneumonia; Urinary Tract Infection
MAUDE report 11211288 ↗
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- Alinity m 09N78-03EAbbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid3 recalls0 reports
- BioFire® Respiratory Panel 2.1 EUA 423738Biofire Diagnostics, LLC · Reagents, 2019-Novel Coronavirus Nucleic Acid3 recalls0 reports
- Alinity m 09N79-05DAbbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid2 recalls0 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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