CLASS II ONGOING Device recall · Reported 22 Mar 2023 · FDA Enforcement Report
In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel recalled
BioFire Diagnostics is recalling In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1), distributed nationwide in the US. The recall was initiated on 1 Feb 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-1252-2023
- FDA event ID
- 91647
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Feb 2023
- FDA classified
- 15 Mar 2023
- Reported
- 22 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Temperature Abuse
- Device type
- CPAP & Ventilators
Timeline
| 1 Feb 2023 | Recall initiated by company | |
| 15 Mar 2023 | Classified by FDA | +42 days |
| 22 Mar 2023 | 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 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.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
Where it was distributed
U.S. Nationwide distribution in the states of FL and GA.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Part Number: 423742 UDI: 00815381020482 Pouch Lot Number: 1551622
Where was it sold?
U.S. Nationwide distribution in the states of FL and GA.
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
2 other products · FDA event 91647This product is part of a recall event; the main page for the event is In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel recalled | BioFire Diagnostics | Temperature Abuse | Nationwide | |
| CLASS II | In Vitro Diagnostic (IVD) Panel FilmArray GI Panel recalled | BioFire Diagnostics | Temperature Abuse | Nationwide |
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, IVD recalled by BioFire Diagnostics | BioFire Diagnostics | Device Malfunction | 10 states |
| Device | CLASS II | BioFire Respiratory Panel 2.1 plus Kit recalled by BioFire Diagnostics | 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 |