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Z-2067-2026Class 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
BioFire Diagnostics, LLC
Product type
Device
Status
Ongoing
Report date
2026-05-13
Distribution
Worldwide - US Nationwide distribution in the states of TX, NC, UT, MD and the countries of France, Italy, Germany, Spain, Belgium, Switzerland, United Kingdom, Netherlands, Poland, Austria, India, Finland, Czech Republic, Egypt, Lebanon, Morocco, Slovenia, Romania, Dominican Republic, Serbia.
Firm state
UT
Product quantity
106 kits (3,180 test)
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Contamination to in-vitro diagnostic test may result in false positives.

Product description

BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

Code / lot info

Lot #s:0883425,0878825/DI: 00815381020192

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

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 →