FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative — Class II medical device recall Z-2609-2025
Ongoing recall by Biofire Defense, reported 2025-10-01, distributed nationwide. FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing p
| Recall number | Z-2609-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biofire Defense, Salt Lake City, UT, United States |
| Recall initiated | 2025-07-10 |
| Classified | 2025-09-19 |
| Reported by FDA | 2025-10-01 |
| Distributed | Nationwide (US) |
| Quantity | 130 kits |
| UPC / GTIN / UDI-DI | 00851458005136 |
Product
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2609-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.