FDA recall Z-1944-2021

Product

FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144

Reason for recall

Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

Distribution

U.S. Nationwide distribution in the states of MN and OK. O.U.S.: None

Key facts

Status

Terminated

Initiation date

2021-04-16

Report date

2021-06-30

Termination date

2024-04-02

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-1944-2021