BioFire Defense recalled 130 FilmArray NGDS Warrior Panel NGDS-ASY-0007 kits distributed nationwide in the United States. The recall cites an increased risk of internal control failures when testing positive blood cultures. Clinicians should stop using the device immediately and follow recall instructions provided by BioFire Defense. Notification is by letter to affected facilities.
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.
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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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.
An increased risk of internal control failures may cause false or delayed test results, potentially delaying diagnosis and appropriate treatment.
This recall is not part of a broader industry pattern.
Delays in diagnostic results can affect patient management and hospital workflow, potentially extending hospital stays and delaying targeted therapies.
Recall notices are issued via letter and posted on FDA enforcement pages. Look for the recall number Z-2609-2025 on official notices.
Replacement or refund processing typically follows the notification timeline set by BioFire Defense; expect 4-6 weeks for processing after submission.
Document notification date, kit lot numbers, UDI-DI, and all communications with BioFire Defense. Retain packaging and labeling for verification.
Model numbers: NGDS-ASY-0007. UDI-DI: 00851458005136. Lot numbers/Expirations: 324324D (2026-02-19), D241022 (2026-01-22), 319524D (2025-11-20), 315424D (2025-10-09), 315224D (2025-10-03), 315324D (2025-10-08). Sold to healthcare facilities nationwide in the United States. Recall date: 2025-07-10.
No injuries or incidents have been reported.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
AvKARE recalled 7,991 cartons of Rosuvastatin Tablets on December 31, 2025. The recall stems from the product being out of specification for dissolution. Consumers should stop using the medication immediately and consult healthcare providers for guidance.
ZOLIQUEX recalled adult portable bed rails sold on Amazon after reports of entrapment and asphyxiation risk. The recall targets silver bed rails measuring 12.4 inches wide by 33.07 inches tall and weighing 7.1 pounds. The model numbers ZEX014-V1 and the Zoliquex branding appear on packaging. Stop using the product and seek a full refund by contacting ZOLIQUEX.
Vitaquest International recalled Arey Not Today iron supplements sold at retailers nationwide after determining the products do not meet the Poison Prevention Packaging Act's child-resistant packaging requirement. The noncompliant packaging creates a poisoning risk to young children if ingested. Consumers should stop using the products immediately and contact Vitaquest for a free child-resistant替换
Easymake adult portable bed rails imported by ZFZG-US are recalled on April 9, 2026. The recall cites a risk of entrapment and asphyxiation and notes the product lacks required hazard warning labels. Stop using the recalled rails immediately and contact ZFZG-US for a full refund.
Taro Pharmaceuticals announced a market withdrawal of Diclofenac Sodium, Topical Gel, 3% on January 27, 2026. The withdrawal stems from out of specification viscosity results. Healthcare providers and consumers should stop using the product immediately.
Sangohe expands its 2026 recall of adult portable bed rails 504E and 504Q due to entrapment and asphyxiation risk. The recall cites noncompliance with the mandatory standard and missing warning labels. Stop using the recalled rails and pursue a full refund by contacting Sangohe.
Tuymec Minoxidil Hair Growth Kit sold on Amazon by DrHealBeauty is recalled for non-child-resistant packaging. The kit contains two black spray bottles with 5% minoxidil and BIOTIN labels. Consumers should stop using the product immediately and contact DrHealBeauty for a free empty replacement bottle with a child-resistant closure.
TecFlox recalled its Minoxidil Topical Solution hair growth serum bottles on April 2, 2026. The packaging is not child-resistant, violating the Poison Prevention Packaging Act. Consumers should stop using the product immediately, store it out of reach of children, and email TecFloxrecall@outlook.com to receive free replacement bottles. Only bottles with serum remaining will be replaced; dispose of