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Updated 2026-08-19

BioFire Diagnostics, LLC recalls BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code:

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Recalled Product

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

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Hazard / Issue

Due to increase in false negative results

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Part Number: 423742 UDI-DI code: 00815381020529 Pouch Lot: 3VLB25 Kit Lot: 1872125

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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Search Amazon for BIOFIRE Respiratory Panel 2.1 →

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