Z-0602-2026Class II

BioFire Diagnostics, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2025-12-03

Distribution

US:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: None

Firm state

Product quantity

97 Kits (2,910 pouches)

Initiated by

Voluntary: Firm initiated

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.

Product description

BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

Code / lot info

UDI: 00815381020529 /Lot # 2649724 Expanded Lot#: 1471725

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →