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.
FDA Recall Z-2609-2025 · Posted 2025-09-19
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Recalling FirmBiofire Defense
Recall StatusOpen, Classified
Product CodePRD
Date Initiated2025-07-10
Product Quantity130 Kits
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.
Firm Action
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]
Root Cause
Component design/selection
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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