FDA recall Z-0602-2026

BioFire Diagnostics, LLC · Class II · device

Product

BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

Reason for recall

Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

Distribution

US Nationwide distribution in the states of ID, OR, AZ.

Key facts

Status
Ongoing
Initiation date
2025-10-22
Report date
2025-12-03
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-0602-2026