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BioFire Diagnostics, LLC: BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic

Medical DevicesSource: FDA (device) · Date: 2026-08-19

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
BioFire Diagnostics, LLC
Product
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based multiplexed nucleic acid test, in vitro diagnostic
Reason / hazard
Due to increase in false negative results
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide distribution in the states of AL, AR, IA, IL, KS, LA, MN, MO, TX, and WI.
Recall initiated
2026-06-24
Code info
Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125
Product quantity
2,370 pouches (79 kits)
Voluntary mandated
Voluntary: Firm initiated
City
Salt Lake City
State
UT
Country
United States
Event id
99261
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