FDA recall Z-2067-2026

Product

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

Reason for recall

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

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.

Key facts

Status

Ongoing

Initiation date

2026-04-22

Report date

2026-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2067-2026