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BIOFIRE Respiratory Panel 2.1
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MEDICAL DEVICE RECALLMODERATE

BIOFIRE Respiratory Panel 2.1

BioFire recalls BIOFIRE Respiratory Panel 2.1 over increased false negatives.

What to do

Do not use the BIOFIRE Respiratory Panel 2.1 test. Contact BioFire Diagnostics for instructions on returning or replacing affected test kits.

Recalled
Listed
Updated
Recall No.
Z-2936-2026
Agency
FDA
Firm
BioFire Diagnostics, LLC
Recall ID
99261
Status
ONGOING

Recall at a glance

Quantity recalled
2,370 pouches (79 kits)

Why it was recalled

BioFire Diagnostics is recalling the BIOFIRE Respiratory Panel 2.1 (RP2.1), a PCR-based multiplexed nucleic acid test for in vitro diagnostics, due to an increase in false negative results.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

Lot code
3VLB25, 1872125

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-08-13 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification