Biofire Defense recalls
Every recall we track for Biofire Defense — 3 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
3 recalls since 2017.
All FDA recall records for Biofire Defense since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
What to do if you have a recalled Biofire Defense product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Biofire Defense recalls
3 shown- Lower riskMedical device
Biofire Defense recalls FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a
Biofire Defense recalls FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 with UDI-DI code (01)00851458005136 due to potential outbreak strain mismatch. Affected units may not detect certain pathogens accurately.
Biofire DefenseJul 16, 2026 - Lower riskMedical device
Biofire Defense recalls FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test
Biofire Defense recalls FilmArray NGDS Warrior Panel NGDS-ASY-0007 due to increased risk of internal control failures when testing positive blood cultures, potentially causing delayed results and extra diagnostic work.
Biofire DefenseJul 10, 2025 - Lower riskMedical device
Biofire Defense recalls FilmArray NGDS Warrior Panel, Ref: NGDS-ASY-0007, UDI: (01)00851458005136, IVD, Rx Only
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.
Biofire DefenseAug 20, 2019
Biofire Defense recall questions
How many recalls has Biofire Defense had?
3 recalls from Biofire Defense are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Biofire Defense recall?
Biofire Defense recalls FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a, dated Jul 16, 2026. Every Biofire Defense recall is listed on this page, newest first.
What should I do if I have a recalled Biofire Defense product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Biofire Defense recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.