Recall Record

Salt Lake City, UT, United States

Biofire Defense recalls

3 recalls recorded since 2018, most recently on 16 July 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
16 July 2026
Reason
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.
Distribution
U.S. Nationwide distribution in the states of AL, CA, DC, FL, GA, HI, KY, LA, MA, MD, MN, NC, NH, NV, NY, OH, RI, TN, TX, UT, VA and WA.
Initiated
Voluntary: Firm initiated
Recall number
Z-2877-2026

Ongoing Class II Medical devices

Recall started
10 July 2025
Reason
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Distribution
US Nationwide distribution in the states of AL, AZ, UT, CA, TX, DC , VA, FL, MD, OH, HI, NY, KY, LA, MA, MI, MN, MO, NC, NH, RI, NV, TN, IA, WA.
Initiated
Voluntary: Firm initiated
Recall number
Z-2609-2025

Terminated Class III Medical devices

Recall started
20 August 2019
Terminated
30 October 2020
Reason
The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.
Distribution
US: UT, MD, GA, CO, OH, TX, OUS: None
Initiated
Voluntary: Firm initiated
Recall number
Z-1448-2020

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.