BioFire Diagnostics, LLC: Medical Device Recall in 2024 - (Recall #: Z-0704-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0 or BIOFIRE FILMARRAY Torch Systems.

Product Classification:

Class II

Date Initiated: November 27, 2023

Date Posted: January 17, 2024

Recall Number: Z-0704-2024

Event ID: 93526

Reason for Recall:

A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.

Status: Ongoing

Product Quantity: 57 Kits

Code Information:

UDI-DI: 00815381020529. Kit Lot/Pouch Lot/Expiration: 1667923/2X2423/June 26, 2024; 1890223/2YHT23/July 26, 2024

Distribution Pattern:

US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD

Voluntary or Mandated:

Voluntary: Firm initiated