Z-2609-2025Class II

FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro...

Name: Z-2609-2025 FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro...
Creator: Biofire Defense
Published: 2025-07-10
License: https://open.fda.gov/license/

BioFire Defense, LLC / initiated 2025-07-10 / Open, Classified / root cause: design

FDA source

Biofire Defense began a recall of 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... on 2025-07-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2609-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-10
Posted: 2025-09-19
Recalling firm: BioFire Defense, LLC
Product: 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.
Product code: PRD
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.
Root cause tag: design
FDA root cause: Component design/selection
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]
Quantity in commerce: 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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2609-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2609-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-19

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)