CLASS II ONGOING Device recall · Reported 30 Aug 2023 · FDA Enforcement Report
BioFire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics
BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 (RP2.1), distributed in 21 states. The recall was initiated on 8 May 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-2439-2023
- FDA event ID
- 92397
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 May 2023
- FDA classified
- 21 Aug 2023
- Reported
- 30 Aug 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 8 May 2023 | Recall initiated by company | |
| 21 Aug 2023 | Classified by FDA | +105 days |
| 30 Aug 2023 | Published in enforcement report | +9 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 manufacturing issue, panels may result in false negative results.
Product as listed by the FDA
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
Where it was distributed
US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia
CaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisLouisianaMassachusettsMichiganMissouriMontanaNorth CarolinaNebraskaNew JerseyNew MexicoNew YorkPennsylvaniaTennesseeUtah
Questions about this recall
Why was it recalled?
Due to manufacturing issue, panels may result in false negative results.
Which lots are affected?
Pouch Lot # 2MRG22 Kit # 2118722 Exp. 12-Nov-23, Pouch Lot # 2N0Z22 Kit # 2151022 Exp. 20-Nov-23, Pouch Lot # 2N1622 Kit # 2151722 Exp. 20-Nov-23, Pouch Lot # 2N1B22 Kit # 2152222 Exp. 20-Nov-23, Pouch Lot # 2N1D22 Kit # 2152422 Exp. 20-Nov-23, Pouch Lot # 2N1G22 Kit # 2152722 Exp. 21-Nov-23, Pouch Lot # 2N2122 Kit # 2154622 Exp. 20-Nov-23, Pouch Lot # 2N2322 Kit # 2154822 Exp. 20-Nov-23, Pouch Lot # 2N2522 Kit # 2155022 Exp. 19-Nov-23, Pouch Lot # 2N2P22 Kit # 2156822 Exp. 23-Nov-23, Pouch Lot # 2N2T22 Kit # 2157222 Exp. 21-Nov-23, Pouch Lot # 2N3022 Kit # 2157922 Exp. 22-Nov-23, Pouch Lot # 2N3222 Kit # 2158122 Exp. 20-Nov-23, Pouch Lot # 2N4C22 Kit # 2162522 Exp. 23-Nov-23, Pouch Lot # 2N4D22 Kit # 2162622 Exp. 23-Nov-23, Pouch Lot # 2N4H22 Kit # 2163022 Exp. 27-Nov-23, Pouch Lot # 2N4Z22 kit # 2164622 Exp. 23-Nov-23, Pouch Lot # 2N5K22 Kit # 2166622 Exp. 23-Nov-23, Pouch Lot # 2N5Y22 Kit # 2167922 Exp. 23-Nov-23, Pouch Lot # 2N6122 Kit # 2168222 Exp. 27-Nov-23, Pouch Lot # 2N6222 Kit # 2168322 Exp. 22-Nov-23, Pouch Lot # 2N6R22 Kit # 2170622 Exp. 23-Nov-23, Pouch Lot # 2N6S22 Kit # 2170722 Exp. 23-Nov-23, Pouch Lot # 2N6W22 Kit # 2171122 Exp. 21-Nov-23, Pouch Lot # 2N6X22 Kit # 2171222 Exp. 22-Nov-23, Pouch Lot # 2N7422 Kit # 2171922 Exp. 26-Nov-23, ;UDI-DI: UDI: 00815381020482
Where was it sold?
US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia
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 92397| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | FilmArray Pneumonia Panel (Pneumo) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | 21 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 |