CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report
The Biofire Respiratory Panel recalled by BioFire Diagnostics
BioFire Diagnostics is recalling The Biofire Respiratory Panel 2.1 (RP2.1) is a Pcr-based multiplexed nucleic acid test, distributed in 16 states. The recall was initiated on 27 Nov 2023 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-0704-2024
- FDA event ID
- 93526
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Nov 2023
- FDA classified
- 10 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- CPAP & Ventilators
Timeline
| 27 Nov 2023 | Recall initiated by company | |
| 10 Jan 2024 | Classified by FDA | +44 days |
| 17 Jan 2024 | 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
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
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
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.
Where it was distributed
US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
CaliforniaConnecticutFloridaIowaIllinoisKansasMassachusettsMarylandMissouriNorth CarolinaNebraskaNew JerseyOhioTennesseeTexasUtah
Questions about this recall
Why was it recalled?
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
Which lots are affected?
UDI-DI: 00815381020529. Kit Lot/Pouch Lot/Expiration: 1667923/2X2423/June 26, 2024; 1890223/2YHT23/July 26, 2024
Where was it sold?
US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
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.
Other products in this recall event
1 other product · FDA event 93526| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Biofire Filmarray Gastrointestinal recalled by BioFire Diagnostics | BioFire Diagnostics | Device Malfunction | 16 states |
More recalls from BioFire Diagnostics
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Multiple-type respiratory pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Multiple-type respiratory pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| 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 |
Other CPAP & Ventilators recalls
All 556| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Multiple-type respiratory pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS II | Multiple-type respiratory pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| 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 |