FilmArray NGDS Warrior Panel Diagnostic Test Recalled Due to Strain Mismatch
Biofire Defense is recalling FilmArray NGDS Warrior Panel kits because the test may not correctly identify certain outbreak strains due to mismatches with the reference strain used during development.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a diagnostic test for high-risk pathogens (e.g., Ebola, Anthrax) where a mismatch poses a risk of harm through potential false negatives, though no illnesses have been reported.
Plain-English summary
Biofire Defense is recalling the FilmArray NGDS Warrior Panel (REF NGDS-ASY-0007), a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test used with the FilmArray 2.0 system. The test is designed to detect and identify Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids from human whole blood.
The manufacturer identified mismatches between the outbreak strains and the reference strain used during the development of this diagnostic panel. This mismatch may affect the test's ability to accurately detect the target pathogens.
This recall affects 122 kits (3,660 pouches) distributed nationwide across several U.S. states, including AL, CA, DC, FL, GA, HI, KY, LA, MA, MD, MN, NC, NH, NV, NY, OH, RI, TN, TX, UT, VA, and WA. Affected lots include 311825D, 312025D, 313526D, and 322925D.
The recalled product
- 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…
- Manufacturer
- Biofire Defense
Distribution
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