Lower riskMedical device recall · FDA · Published August 20, 2019
Biofire Defense FilmArray NGDS Warrior Panel Recall: Incorrect Instruction for Use
Biofire Defense recalls FilmArray NGDS Warrior Panel (Ref: NGDS-ASY-0007) due to an incorrect instruction for use in the in vitro diagnostic test kit. Affected units include specific lot numbers with expiration dates through 2020-05-30.
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.
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Contact the company
📍Recalling firmBiofire Defense79 W 4500 S, Ste 14 · Salt Lake City, UT 84107-2649
“Biofire Defense FilmArray NGDS Warrior Panel Recall: Incorrect Instruction for Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67146-biofire-defense-filmarray-ngds-warrior-panel-recall-incorrect-instruction-for. Based on FDA recall #Z-1448-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1448-2020%22&limit=1).
The FDA announced on 2019-08-20 that Biofire Defense is recalling FilmArray NGDS Warrior Panels because an incorrect instruction for use was included, according to the FDA. Owners should contact the firm for a remedy.
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, according to the FDA.
Context
GovInfoNow's records show Biofire Defense has 2 other recalls on record since 2025-07-10. Other recent recalls of similar products include BioFire Joint Infection Panel Recall (2026-04-22), BioFire Spotfire Respiratory Panel Recall (2026-04-01), and BioFire Respiratory Panel 2.1 (2026-06-24).
How to tell if you have this one
Check the product label for the lot number and expiration date. Affected units include specific lot numbers listed in the recall notice, such as 457117D/2018-10-17 through 462819D/2020-06-10.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1448-2020 (August 20, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1448-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.