Biofire Defense Warrior Panel test recalled for strain mismatch
Biofire Defense is recalling 122 kits (3,660 pouches) of the FilmArray NGDS Warrior Panel, a test that detects several dangerous pathogens in human whole blood. The firm found mismatches between the outbreak strain and the reference strain used to develop the test. The notice reports no injuries.
From the FDA notice · Read the official notice ↗
What to do
- Set aside lots 311825D, 312025D, 313526D and 322925D so they are not used for testing.
- Contact Biofire Defense for next steps, since the notice does not specify a remedy.
- Check the part number NGDS-ASY-0007 and UDI-DI code (01)00851458005136 on your kits to identify affected product.
Is yours affected?
Compare your label or packaging with 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 and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 122 kits (3,660 pouches)
- Illnesses reported
- None reported
- Manufactured in
- 79 W 4500 S Ste 14, Salt Lake City, UT, United States
- Classification
- Class II
- Recall number
- Z-2877-2026
In the FDA's words
- Description
- 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). 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. Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D Distribution: U.S. Nationwide distribution in the states of AL, CA, DC, FL, GA, HI, KY, LA, MA, MD, MN, NC, NH, NV, NY, OH, RI, TN, TX, UT, VA and WA. Affected quantity: 122 kits (3,660 pouches)
- Hazard
- 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.