Recall archive / FDA device enforcement
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only — FDA record Z-2439-2023
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
- BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only
- Reason
- Due to manufacturing issue, panels may result in false negative results.
- Classification
- Class II
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 705 kits (30 pouches/kit)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2439-2023
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 # 2MRG22 Kit # 2118722 Exp. 12-Nov-23, Pouch Lot # 2N0Z22 Kit # 2151022 Exp. 20-Nov-23, Pouch Lot # 2N1622 Kit # 2151722 Exp. 20-Nov-23, Pouch Lot # 2N1B22 Kit # 2152222 Exp. 20-Nov-23, Pouch Lot # 2N1D22 Kit # 2152422 Exp. 20-Nov-23, Pouch Lot # 2N1G22 Kit # 2152722 Exp. 21-Nov-23, Pouch Lot # 2N2122 Kit # 2154622 Exp. 20-Nov-23, Pouch Lot # 2N2322 Kit # 2154822 Exp. 20-Nov-23, Pouch Lot # 2N2522 Kit # 2155022 Exp. 19-Nov-23, Pouch Lot # 2N2P22 Kit # 2156822 Exp. 23-Nov-23, Pouch Lot # 2N2T22 Kit # 2157222 Exp. 21-Nov-23, Pouch Lot # 2N3022 Kit # 2157922 Exp. 22-Nov-23, Pouch Lot # 2N3222 Kit # 2158122 Exp. 20-Nov-23, Pouch Lot # 2N4C22 Kit # 2162522 Exp. 23-Nov-23, Pouch Lot # 2N4D22 Kit # 2162622 Exp. 23-Nov-23, Pouch Lot # 2N4H22 Kit # 2163022 Exp. 27-Nov-23, Pouch Lot # 2N4Z22 kit # 2164622 Exp. 23-Nov-23, Pouch Lot # 2N5K22 Kit # 2166622 Exp. 23-Nov-23, Pouch Lot # 2N5Y22 Kit # 2167922 Exp. 23-Nov-23, Pouch Lot # 2N6122 Kit # 2168222 Exp. 27-Nov-23, Pouch Lot # 2N6222 Kit # 2168322 Exp. 22-Nov-23, Pouch Lot # 2N6R22 Kit # 2170622 Exp. 23-Nov-23, Pouch Lot # 2N6S22 Kit # 2170722 Exp. 23-Nov-23, Pouch Lot # 2N6W22 Kit # 2171122 Exp. 21-Nov-23, Pouch Lot # 2N6X22 Kit # 2171222 Exp. 22-Nov-23, Pouch Lot # 2N7422 Kit # 2171922 Exp. 26-Nov-23, ;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.