CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report
BioFire Respiratory Panel 2.1, IVD recalled by BioFire Diagnostics
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1, IVD, distributed in 10 states. The recall was initiated on 22 Oct 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0602-2026
- FDA event ID
- 97870
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Oct 2025
- FDA classified
- 26 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 22 Oct 2025 | Recall initiated by company | |
| 26 Nov 2025 | Classified by FDA | +35 days |
| 3 Dec 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Where it was distributed
US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
ArizonaFloridaGeorgiaNorth CarolinaNew HampshireNew JerseyNew YorkOregonPennsylvaniaSouth Carolina
Questions about this recall
Why was it recalled?
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Which lots are affected?
UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725
Where was it sold?
US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from BioFire Diagnostics
All 44| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS II | Biofire Spotfire Respiratory/Sore Throat Panel recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | BioFire Joint Infection (JI) Panel recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS II | BioFire Respiratory Panel 2.1 plus Kit recalled by BioFire Diagnostics | BioFire Diagnostics | Device Malfunction | UT |
| Device | CLASS II | FilmArra Pneumonia Panel plus (Pneumoplus) recalled | BioFire Diagnostics | Device Malfunction | UT |
Other CPAP & Ventilators recalls
All 554| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |