Class II — BioFire Diagnostics, LLC
| Recalling firm | BioFire Diagnostics, LLC |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to increase in false negative results |
| Product | BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic |
| Quantity | 2,370 pouches (79 kits) |
| Distribution | U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI. |
| Initiated | 2026-06-24 |
| Classified | 2026-08-12 |
| Recall number | Z-2936-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — BioFire Diagnostics, LLC (Z-2936-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99261/
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