FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test in
FDA device recall Z-2609-2025 · posted 2025-09-19 · Open, Classified
Recall details
- Recalling firm
- Biofire Defense
- 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.
- Action taken
- 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 support@biofiredefense.com
- Root cause
- Component design/selection
- Status
- Open, Classified
- Product code
- PRD
- Quantity 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.
- Date initiated
- 2025-07-10
- Date posted
- 2025-09-19
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FilmArray NGDS Warrior Panel (K170883) | Biofire Defense, LLC | 2017-06-22 |