FilmArray NGDS Warrior Panel — Class III medical device recall Z-1448-2020
Terminated recall by Biofire Defense, reported 2020-03-11, distributed in CO, GA, MD, OH, TX, UT. The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative,
| Recall number | Z-1448-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biofire Defense, Salt Lake City, UT, United States |
| Recall initiated | 2019-08-20 |
| Classified | 2020-03-05 |
| Reported by FDA | 2020-03-11 |
| Terminated | 2020-10-30 |
| Distributed | CO, GA, MD, OH, TX, UT |
| Quantity | 92 kits |
| UPC / GTIN / UDI-DI | 00851458005136 |
| Lot numbers | 416118D, 425719D, 439218D, 439318D, 454218D, 454318D, 455518D, 457117D, 458018D, 458118D, 458218D, 462819D, 464018D |
| Model numbers | NGDS-ASY-0007 |
Product
FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
Reason for recall
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.
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-1448-2020. 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.