FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a recall
FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the…
Why was FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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)
- Product
- FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the…
- Recalling firm
- Biofire Defense
- Quantity
- 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.
- Recall date
- October 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)