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Biofire Defense recall records

2 reported ongoing

2 records in this archive. Latest source date Jul 16, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagno...

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.

Class IIReported ongoing

Distribution: U.S. Nationwide distribution in the states of AL, CA, DC, FL, GA, HI, KY, LA, MA, MD, MN, NC, NH, NV, NY, OH, RI, TN, TX, UT, VA and WA.

Official source
FDA device enforcement

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.

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.

Class IIReported ongoing

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.

Official source

Reasons in these listed records

  • 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.
  • 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.

These examples come from this result page and are not a ranking of every recall reason.

Checking Biofire Defense

Is there a recall on biofire defense right now?

This archive contains 2 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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