BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Summary
The FDA issued a Class II for BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) by BioFire Diagnostics, LLC. Reason: Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures..
Details
Source
Device Recall
External ID
Z-0602-2026
Action Date
2025-12-03
Status
Ongoing
Category
device
Product Description
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Lot/Code Info: UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725
Quantity Affected: 97 Kits (2,910 pouches)
Reason for Recall
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
Distribution
US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-22
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 254 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-0602-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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