Reported May 13, 2026 · Ongoing

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

BioFire Diagnostics, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BioFire Diagnostics, LLC · 515 S Colorow Dr · Salt Lake City, UT · 84108-1248

Is this the product you have?

  • BioFire Joint Infection (JI) Panel REF
    • RFIT-ASY-0138
    • 30 test Kit
Lot codes and dates
    • Lot #s:0883425
    • 0878825/DI: 00815381020192
Amount recalled
106 kits (3,180 test)

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.