Z-2877-2026Class II

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior...

Name: Z-2877-2026 FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior...
Creator: Biofire Defense
Published: 2026-07-16
License: https://open.fda.gov/license/

BioFire Defense, LLC / initiated 2026-07-16 / Open, Classified

FDA source

Biofire Defense began a recall of FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic... on 2026-07-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2877-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-16
Posted: 2026-08-04
Recalling firm: BioFire Defense, LLC
Product: 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).
Product code: PRD
Reason for recall: 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: Under Investigation by firm
Action: 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.
Quantity in commerce: 122 kits (3,660 pouches)
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 codes and lots: Part Number: NGDS-ASY-0007 UDI-DI code: (01)00851458005136 Lot Numbers: 311825D 312025D 313526D 322925D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2877-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2877-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-08-12	2026-08-04

Product code PRD

K170883FilmArray NGDS Warrior PanelBiofire Defense, LLC / cleared 2017-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)