FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a… recallZ-2609-2025 · Biofire Defense · initiated Jul 10, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biofire Defense or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Component design/selection
What the company is doing
On 7/10/2025, correction notices were mailed and emailed to customers who were asked to do the following: - If testing with only whole blood and/or sputum, there is no impact to the product s performance. Continue using panel kits as planned. - If testing with positive blood culture may occur, discontinue use, dispose of impacted kit(s) according to your lab s procedures, and only use replacement kits provided, or use impacted lots only with whole blood and/or sputum sample types. - Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties who may use this product, including others to whom you may have transferred our product. - Complete and return the acknowledgment of receipt form via email to [email protected]
Recall details
- Recall number
- Z-2609-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 10, 2025
- Posted by the FDA
- Sep 19, 2025
- Recalling firm
- Biofire Defense
- Quantity
- 130 Kits
- Product code
- PRD
- FDA submissions
- K170883
- 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.
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.
Code information (models, lots, serial numbers)
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)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- FilmArray® NGDS Warrior Panel NGDS-ASY-0007Biofire Defense, LLC · Biothreat Microbial Agents Multiplex Nucleic Acid Detection System2 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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