Recall Atlas

Biofire Defense recalls

2 official recalls and safety alerts involving Biofire Defense since 2025-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Biofire Defense or the relevant agency.

  1. 2026-08-12
  2. US
    Drugs & medicalClass II

    Biofire Defense recalls FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative,…

    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 · DeviceBiofire DefenseU.S. Nationwide distribution in the states of AL, CA, DC, FL, GA, HI, KY, LA,…Official notice →
  3. 2025-10-01
  4. US
    Drugs & medicalClass II

    Biofire Defense recalls FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use…

    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.

    FDA · DeviceBiofire DefenseUS Nationwide distribution in the states of AL, AZ, UT, CA, TX, DC , VA, FL,…Official notice →