HIGH

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

Respiratory/sore throat panel test may result in false negative results and control failures.

Quick Facts at a Glance

Recall Date
April 1, 2026
Hazard Level
HIGH
Brand
BioFire Diagnostics
Geographic Scope
1 states

Hazard Information

Respiratory/sore throat panel test may result in false negative results and control failures.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BioFire Diagnostics, LLC or your healthcare provider for instructions. Notification method: E-Mail

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Full Description

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485. Reason: Respiratory/sore throat panel test may result in false negative results and control failures.. Classification: Class II. Quantity: 2400 pouches. Distribution: US Nationwide distribution in the states of MS, TX MN, VA.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lot Number: 2215125/UDI: 00815381020390
Affected States
ALL
Report Date
May 13, 2026
Recall Status
ACTIVE