BioFire Diagnostics, LLC: Medical Device Recall in 2023 - (Recall #: Z-2440-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only

Product Classification:

Class II

Date Initiated: May 8, 2023

Date Posted: August 30, 2023

Recall Number: Z-2440-2023

Event ID: 92397

Reason for Recall:

Due to manufacturing issue, panels may result in false negative results.

Status: Ongoing

Product Quantity: 24 Kits (30 pouches/kit)

Code Information:

Pouch Lot # 2NBT22 /Kit # 2187822 ;UDI-DI: UDI: 00815381020482

Distribution Pattern:

US: CA CO CT FL GA IA IL IN LA MA MI MO MT NC NE NJ NM NY OH OK PA TN UT WV OUS: Canada, India, Japan, Singapore, Colombia

Voluntary or Mandated:

Voluntary: Firm initiated