FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: — Class II medical device recall Z-2877-2026
Ongoing recall by Biofire Defense, reported 2026-08-12, distributed nationwide. Firm has identified mismatches between the outbreak strain and the reference strain used in the development of
| Recall number | Z-2877-2026 |
|---|---|
| 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 | 2026-07-16 |
| Classified | 2026-08-04 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 00851458005136 |
| Lot numbers | 311825D, 312025D, 313526D, 322925D |
| Model numbers | NGDS-ASY-0007 |
Product
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).
Reason for recall
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.
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-2877-2026. 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.