CLASS II ONGOING Device recall · Reported 16 Apr 2025 · FDA Enforcement Report
FilmArra Pneumonia Panel plus (Pneumoplus) recalled
BioFire Diagnostics is recalling FilmArra Pneumonia Panel plus (Pneumoplus). The recall was initiated on 27 Feb 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-1518-2025
- FDA event ID
- 96346
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Feb 2025
- FDA classified
- 4 Apr 2025
- Reported
- 16 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 27 Feb 2025 | Recall initiated by company | |
| 4 Apr 2025 | Classified by FDA | +36 days |
| 16 Apr 2025 | 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
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
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
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Where it was distributed
OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
Questions about this recall
Why was it recalled?
Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
Which lots are affected?
UDI: 00815381020314/Lot# 0979424
Where was it sold?
OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
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.
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