Recall archive / FDA device enforcement
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only — FDA record Z-2440-2023
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 May 8, 2023. 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
- FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only
- Reason
- Due to manufacturing issue, panels may result in false negative results.
- Classification
- Class II
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 24 Kits (30 pouches/kit)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2440-2023
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 | Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Aug 30, 2023
- Recall initiation date
- May 8, 2023
- Center classification date
- Aug 21, 2023
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.