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FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 recallZ-2877-2026 · Biofire Defense · initiated Jul 16, 2026

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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

Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic panel test.

FDA root cause category: Under Investigation by firm

What the company is doing

On 07/16/2026, an "ADVISORY NOTICE URGENT: MEDICAL DEVICE CORRECTION" Letter was sent via FedEx Priority Overnight to customer informing them that, due to the emergence of the 2026 Bundibugyo outbreak strain, BioFire Defense has conducted testing to evaluate performance of the Orthoebolavirus spp. assays on the FilmArray NGDS Warrior Panel. This preliminary testing has identified a potential reduction in sensitivity to the 2026 Bundibugyo outbreak strain which could result in Orthoebolavirus spp. Not Detected results when testing on the FilmArray NGDS Warrior Panel. Customers are instructed to: " Distribute this letter and the updated IFU (revision 5) to all appropriate personnel in your laboratory, retain a copy in your files, and forward this information to all parties that may use this product including others to whom you may have transferred FilmArray NGDS Warrior Panel product. Please follow applicable ITAR protocols for distribution. " Train and ensure awareness by laboratory personnel on the Additional Information and Required Actions included in the updated IFU (Table 6, Pg. 24). " Complete the Acknowledgement of Receipt. The web form can be found here: https://go.biofiredefense.com/FSCA-2601-Warrior-potential-ebola-not-detected-US or fill out the accompanying document. For Questions - contact BioFire Defense Customer Technical Support at [email protected] or via telephone at 1-801-262-3592.

Recall details

Recall number
Z-2877-2026
Status
Open, Classified
Initiated by the company
Jul 16, 2026
Posted by the FDA
Aug 4, 2026
Recalling firm
Biofire Defense
Quantity
122 kits (3,660 pouches)
Product code
PRD
FDA submissions
K170883
Distribution
U.S. Nationwide distribution in the states of AL, CA, DC, FL, GA, HI, KY, LA, MA, MD, MN, NC, NH, NV, NY, OH, RI, TN, TX, UT, VA and WA.

Product description

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects and identifies Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, and Marburg virus nucleic acids directly from human whole blood (EDTA).

Code information (models, lots, serial numbers)

Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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