CLASS II ONGOING Device recall · Reported 28 Aug 2024 · FDA Enforcement Report
Biofire Filmarray Pneumonia Panel plus recalled by BioFire Diagnostics
BioFire Diagnostics is recalling Biofire Filmarray Pneumonia Panel plus, distributed nationwide in the US. The recall was initiated on 10 Jun 2024 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-2683-2024
- FDA event ID
- 94942
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Jun 2024
- FDA classified
- 16 Aug 2024
- Reported
- 28 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 10 Jun 2024 | Recall initiated by company | |
| 16 Aug 2024 | Classified by FDA | +67 days |
| 28 Aug 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
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 FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Where it was distributed
Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.
Questions about this recall
Why was it recalled?
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
Which lots are affected?
UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024
Where was it sold?
Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.
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 94942| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Biofire Filmarray Pneumonia Panel recalled by BioFire Diagnostics | BioFire Diagnostics | Device Malfunction | Nationwide |
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 |
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