Recall Z-2081-2026— BioFire Diagnostics, LLC

Name: FDA recall Z-2081-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-01

Class II · Ongoing

Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2026-04-01. It names one FDA 510(k) clearance: K232954. Product: Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485. Reason: Respiratory/sore throat panel test may result in false negative results and control failures..

Recalling firm: BioFire Diagnostics, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-04-01
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K232954 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelBiofire Diagnostics, LLC·cleared 2024-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.