Biofire Defense recalls FilmArray NGDS Warrior Panel NGDS-ASY-0007 due to increased risk of internal control failures when testing positive blood cultures, potentially causing delayed results and extra diagnostic work.
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.
Biofire Defense is recalling its FilmArray NGDS Warrior Panel NGDS-ASY-0007 diagnostic test because it can fail internal controls when testing positive blood cultures, leading to delayed results and extra testing. This affects labs using the product for blood culture diagnostics.
The panel may fail internal controls when testing positive blood cultures, causing delayed results and requiring additional diagnostic work. This happens because the internal control mechanism isn't working properly under certain test conditions.
Laboratories using the FilmArray NGDS Warrior Panel NGDS-ASY-0007 for blood culture diagnostics are most affected. The risk is low for end-users as it's a lab test.
Check for the model number NGDS-ASY-0007 on the panel. The product was sold with specific expiration dates listed in the recall notice.
Identify the model number NGDS-ASY-0007 on the panel to confirm if it's affected.
The panel has an increased risk of internal control failures when testing positive blood cultures, which may lead to delayed results and additional diagnostic workup.
Look for the model number NGDS-ASY-0007 on the panel. The product was sold with specific expiration dates listed in the recall notice.
The recall does not specify a remedy, so check with Biofire Defense for further instructions.
We’ve drafted a message you can send Biofire Defense to request your refund or repair — edit it as you like.
Subject: Recall Z-2609-2025 — Biofire Defense Biofire Defense Hello, I own a Biofire Defense that is covered by recall Z-2609-2025 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.
