Biofire Defense recalls FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 with UDI-DI code (01)00851458005136 due to potential outbreak strain mismatch. Affected units may not detect certain pathogens accurately.
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.
Biofire Defense is recalling a specific version of their FilmArray NGDS Warrior Panel diagnostic test because it may not match the outbreak strain used in real-world testing. This could lead to inaccurate results for detecting certain dangerous pathogens like anthrax and Ebola.
The test may not correctly identify certain pathogens in samples because the outbreak strain used in real-world testing doesn't match the reference strain used during development. This could lead to false negative results, meaning dangerous infections might go undetected.
Laboratory users who purchased the FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 with UDI-DI code (01)00851458005136. Those testing for anthrax, plague, tularemia, Q fever, or Ebola/Marburg viruses are most at risk of inaccurate results.
Check for the product code REF NGDS-ASY-0007 and UDI-DI code (01)00851458005136 on the panel. Lot numbers 311825D, 312025D, 313526D, and 322925D are also affected.
Verify the product code REF NGDS-ASY-0007 and UDI-DI code (01)00851458005136 on the panel.
The recall is due to potential mismatches between the outbreak strain and the reference strain used in development, which could lead to inaccurate results for certain pathogens.
The test may not detect Bacillus anthracis, Yersinia pestis, Francisella tularensis, Coxiella burnetii, Ebola virus, or Marburg virus accurately in some cases.
Look for the product code REF NGDS-ASY-0007 and UDI-DI code (01)00851458005136, or lot numbers 311825D, 312025D, 313526D, and 322925D.
We’ve drafted a message you can send Biofire Defense to request your refund or repair — edit it as you like.
Subject: Recall Z-2877-2026 — Biofire Defense Biofire Defense Hello, I own a Biofire Defense that is covered by recall Z-2877-2026 from Biofire Defense. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
