BioFire® Respiratory Panel 2.1 EUA 423738Recalls & reported problems
Biofire Diagnostics, LLC · IVD reagent kit containing 30 tests. · Class N
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name 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
- 3
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
3 FDA recall records name this device's identifier, 3 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
- May 8, 2023Class IIOpen, Classified
Due to manufacturing issue, panels may result in false negative results.
Z-2439-2023 · Root cause: Process design · Recall details · FDA record ↗
- May 8, 2023Class IIOpen, Classified
Due to manufacturing issue, panels may result in false negative results.
Z-2440-2023 · Root cause: Process design · Recall details · FDA record ↗
- Feb 1, 2023Class IIOpen, Classified
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance. The temperature excursion was as a result of shipping delays.
Z-1252-2023 · Root cause: Environmental control · Recall details · FDA record ↗
Other Reagents, 2019-Novel Coronavirus Nucleic Acid devices
- ID NOW™ COVID-19 190-000Alere Scarborough, Inc. · Reagents, 2019-Novel Coronavirus Nucleic Acid4 deaths1,932 reports
- Alinity m 09N78-095Abbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid3 recalls357 reports
- Lyra CoronavirusDiagnostic Hybrids, Inc. · Reagents, 2019-novel coronavirus nucleic acid403 reports
- Solana SARS-CoV-2 Assay CoronavirusDiagnostic Hybrids, Inc. · Reagents, 2019-novel coronavirus nucleic acid328 reports
- Alinity m 09N79-096Abbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid2 recalls179 reports
- Alinity m 09N78-03EAbbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid3 recalls0 reports
- Alinity m 09N79-05DAbbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid2 recalls0 reports
- Alinity m 09N78-085Abbott Molecular Inc. · Reagents, 2019-novel coronavirus nucleic acid1 recall42 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
- 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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