FDA recall Z-2081-2026

BioFire Diagnostics, LLC · Class II · device

Product

Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485

Reason for recall

Respiratory/sore throat panel test may result in false negative results and control failures.

Distribution

US Nationwide distribution in the states of MS, TX MN, VA.

Key facts

Status: Ongoing
Initiation date: 2026-04-01
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-2081-2026