Quick Facts at a Glance
- Recall Date
- July 10, 2025
- Hazard Level
- HIGH
- Brand
- BioFire Defense
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BioFire Defense
- Product type
- In Vitro Diagnostic Test
- Model numbers
- NGDS-ASY-0007, UDI-DI: 00851458005136
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 10, 2025
Reported by FDA DEVICE
October 1, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Biofire Defense or your healthcare provider for instructions. Notification method: Letter
About This Product
The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test used with the FilmArray 2.0 system. It is designed to rapidly identify pathogens in positive blood culture specimens.
Why This Is Dangerous
An increased risk of internal control failures may cause false or delayed test results, potentially delaying diagnosis and appropriate treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Delays in diagnostic results can affect patient management and hospital workflow, potentially extending hospital stays and delaying targeted therapies.
Practical Guidance
How to identify if yours is affected
- Confirm kit is NGDS Warrior Panel NGDS-ASY-0007 by checking model number on the packaging and device.
- Verify UDI-DI 00851458005136 on the label.
Where to find product info
Recall notices are issued via letter and posted on FDA enforcement pages. Look for the recall number Z-2609-2025 on official notices.
What timeline to expect
Replacement or refund processing typically follows the notification timeline set by BioFire Defense; expect 4-6 weeks for processing after submission.
If the manufacturer is unresponsive
- Escalate to hospital compliance or biosafety officer.
- Consider contacting regulatory authorities if the company is non-responsive.
How to prevent similar issues
- Verify device recalls before placing orders.
- Keep an updated inventory of all diagnostic kits with lot numbers and UDI-DI.
- Establish a clear line of communication with suppliers for recall handling.
Documentation advice
Document notification date, kit lot numbers, UDI-DI, and all communications with BioFire Defense. Retain packaging and labeling for verification.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- NAS distribution across 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
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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