Recall archive / FDA device enforcement
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) — FDA record Z-0602-2026
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 Oct 22, 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, IVD, REF: 423742 (30 test kit)
- Reason
- Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
- Classification
- Class II
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 97 Kits (2,910 pouches)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0602-2026
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: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
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
- Dec 3, 2025
- Recall initiation date
- Oct 22, 2025
- Center classification date
- Nov 26, 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.