The Recall Desk
ModerateFDA (Devices)·Z-2609-2025·Announced 2025-10-01

FilmArray NGDS Warrior Panel diagnostic test system recall notice

Biofire Defense is recalling the FilmArray NGDS Warrior Panel due to increased risk of internal control failures when testing positive blood cultures, which may delay results and require additional diagnostic evaluation.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The hazard is an internal control failure that may delay results and require additional diagnostic workup, but no reported illnesses or injuries are stated in the source. The defect is functional rather than presenting direct patient harm, placing it in the Moderate category.

Plain-English summary

Biofire Defense is recalling the FilmArray NGDS Warrior Panel NGDS-ASY-0007, a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test used with the FilmArray 2.0 system. The device has an increased risk of internal control failures when testing positive blood cultures, which may lead to delayed results and additional diagnostic workup.

The recall affects approximately 130 kits distributed nationwide. Affected lot numbers are 324324D (expiration 2026-02-19), D241022 (expiration 2026-01-22), 319524D (expiration 2025-11-20), 315424D (expiration 2025-10-09), 315224D (expiration 2025-10-03), and 315324D (expiration 2025-10-08). The affected states include Alabama, Arizona, Utah, California, Texas, DC, Virginia, Florida, Maryland, Ohio, Hawaii, New York, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, Rhode Island, Nevada, Tennessee, Iowa, and Washington.

Healthcare providers using affected kits should contact Biofire Defense for instructions on return or replacement. Users should be aware of the potential for internal control failures when the device is used with positive blood cultures.

The recalled product

Product
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system.
Manufacturer
Biofire Defense
Category
Medical Device — In Vitro Diagnostic Test
Hazard
  • control-failure
  • delayed-results

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • UDI-DI: 00851458005136. Lot(Expiration): 324324D(2026-02-19)
  • D241022(2026-01-22)
  • 319524D(2025-11-20)
  • 315424D(2025-10-09)
  • 315224D(2025-10-03)
  • 315324D(2025-10-08)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category