Limited official informationFDA Medical Device Enforcement ReportsRecall date: May 13, 2026

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

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 3, 2026, 11:43 PM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.Lot #s:0883425,0878825/DI: 00815381020192106 kits (3,180 test)Z-2067-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

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.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.