Recall archive / FDA device enforcement
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems — FDA record Z-1877-2025
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 Apr 30, 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
- BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
- Reason
- Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
- Classification
- Class II
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 30 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1877-2025
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 | Lot# 1475424/ UDI: None |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the country of Singapore.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jun 4, 2025
- Recall initiation date
- Apr 30, 2025
- Center classification date
- May 29, 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.