# K170883: FilmArray NGDS Warrior Panel

- Pathway: 510(k) (Traditional)
- Applicant: Biofire Defense, LLC
- Decided: Jun 22, 2017 after 90 days
- Product code: PRD
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K213362: BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the BioFire Global Fever Special Pathogens Panel (2023), 2 descendants of its own
- K253653: Xpert Hemorrhagic Fever (2026), 1 descendant of its own
- K252072: Francisella tularensis Real-time PCR assay (2025), 1 descendant of its own
- K261362: Xpert Hemorrhagic Fever (2026), 0 descendants of its own
- K260812: Francisella tularensis Real-time PCR Assay (2026), 0 descendants of its own

## Recalls of this device
- Jul 16, 2026 · Class II · Z-2877-2026: 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.
- Jul 10, 2025 · Class II · Z-2609-2025: 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.
- Aug 20, 2019 · Class III · Z-1448-2020: 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.

Source page: https://510kreport.com/device/K170883
Methodology: https://510kreport.com/methodology