DeviceSignal · Recall classified
Biofire Defense
FDA classified a device recall on 2026-08-04 · Class II · Z-2877-2026
EventRecall classified
Effective2026-08-04
ClassificationClass II
On 2026-08-04 the FDA classified a device recall from Biofire Defense as Class II. Product: FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The…. Recall Z-2877-2026. The firm initiated it on 2026-07-16. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2877-2026
- Classification
- Class II
- Classified on
- 2026-08-04
- Initiated on
- 2026-07-16
- Firm
- Biofire Defense
- Reason
- 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.
- 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).
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2877-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
e49c17f8048ff0a4a36ba8d1e6ce0ee2dd49f8b2ab0b0d6fa1b25564bedfa4c8- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)