BioFire Diagnostics, LLC: Medical Device Recall in 2021 - (Recall #: Z-1944-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 16, 2021

Date Posted: June 30, 2021

Recall Number: Z-1944-2021

Event ID: 87936

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.

Status: Terminated

Product Quantity: 9 kits (U.S. only)

Code Information:

Part Number:RFIT-ASY-0144 UDI: 00815381020178 Kit Lot#: 0938121 Pouch Lot#: 19T621

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated