Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BioFire Respiratory Panel 2.1 plus Kit Recalled by BioFire Diagnostics, LLC Due to Due to manufacturing error, respiratory panel may result...

Date: April 30, 2025
Company: BioFire Diagnostics, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact BioFire Diagnostics, LLC directly.

Affected Products

BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

Quantity: 30 kits

Why Was This Recalled?

Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

Where Was This Sold?

International distribution in the country of Singapore.

About BioFire Diagnostics, LLC

BioFire Diagnostics, LLC has 40 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report