FDA recall Z-1877-2025

BioFire Diagnostics, LLC · Class II · device

Product

BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems

Reason for recall

Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.

Distribution

International distribution in the country of Singapore.

Key facts

Status
Ongoing
Initiation date
2025-04-30
Report date
2025-06-04
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-1877-2025