BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Due to increase in false negative results
| Recalling firm | BioFire Diagnostics, LLC |
|---|---|
| Reason | Due to increase in false negative results |
| Risk class | Class II (Class II · moderate) |
| Status | Ongoing |
| Report date | Aug 19, 2026 |
| Initiated | Jun 24, 2026 |
| Region | UT, United States |
| Distribution | U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI. |
| Quantity | 2,370 pouches (79 kits) |
| Code/Lot | Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125 |
| Type | Voluntary: Firm initiated |
| Recall number | Z-2936-2026 |
Official source
U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗You can re-verify each item on the official FDA site using its recall number. (Recall number: Z-2936-2026)
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