Summary
The FDA issued a Class II for Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 by BioFire Diagnostics, LLC. Reason: Respiratory/sore throat panel test may result in false negative results and control failures..
Details
Source
Device Recall
External ID
Z-2081-2026
Action Date
2026-05-13
Status
Ongoing
Category
device
Product Description
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485
Lot/Code Info: Lot Number: 2215125/UDI: 00815381020390
Quantity Affected: 2400 pouches
Reason for Recall
Respiratory/sore throat panel test may result in false negative results and control failures.
Distribution
US Nationwide distribution in the states of MS, TX MN, VA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-01
Company
Salt Lake City, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 250 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BioFire Diagnostics, LLC has 41 FDA actions in our database, including 30 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioFire Diagnostics, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioFire Diagnostics, LLC have FDA actions?
BioFire Diagnostics, LLC has 41 FDA actions in our database, including 30 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2081-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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