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.
Reported: October 1, 2025 Initiated: July 10, 2025 #Z-2609-2025
Product Description
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.
Reason for Recall
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Details
- Recalling Firm
- Biofire Defense
- Units Affected
- 130 Kits
- Distribution
- US Nationwide distribution in the states of AL, AZ, UT, CA, TX, DC , VA, FL, MD, OH, HI, NY, KY, LA, MA, MI, MN, MO, NC, NH, RI, NV, TN, IA, WA.
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biofire Defense. Units affected: 130 Kits.
Why was this product recalled? ▼
FilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead to delayed results and additional diagnostic workup.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 1, 2025. Severity: Moderate. Recall number: Z-2609-2025.
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