FilmArray NGDS Warrior Panel Diagnostic Test Kits Recalled for Control Failures
Biofire Defense is recalling 130 kits of the FilmArray NGDS Warrior Panel diagnostic test due to increased risk of internal control failures when testing positive blood cultures, which may delay test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a functional defect in a diagnostic test that may produce delayed results and impact diagnostic accuracy, meeting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Biofire Defense is recalling 130 kits of the FilmArray NGDS Warrior Panel (NGDS-ASY-0007), a qualitative, multiplexed nucleic acid-based in vitro diagnostic test for use with the FilmArray 2.0 system. The recalled kits were distributed nationwide across 24 states and the District of Columbia.
The recall addresses an increased risk of internal control failures when the test is used to analyze positive blood cultures. These control failures may cause delayed test results and necessitate additional diagnostic workup, potentially impacting clinical decision-making.
Healthcare facilities and laboratories that received affected kits should contact Biofire Defense for further guidance. Specific lot numbers and expiration dates are listed in the official recall notice (FDA Z-2609-2025). Affected facilities should review their inventory and consider alternative testing methods for samples pending resolution.
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
- 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.
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