Recall archive / FDA device enforcement
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 — FDA record Z-1518-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 27, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
- Reason
- Increased risk of control failures and false negative test results with multiplexed nucleic acid test.
- Classification
- Class II
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 29 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1518-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: 00815381020314/Lot# 0979424 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
OUS International Distribution to countries of: France, Italia, Spain, Switzerland, Israel
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 16, 2025
- Recall initiation date
- Feb 27, 2025
- Center classification date
- Apr 4, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.