Biofire Defense recalls FilmArray NGDS Warrior Panel (Ref: NGDS-ASY-0007) due to an incorrect instruction for use in the in vitro diagnostic test kit. Affected units include specific lot numbers with expiration dates through 2020-05-30.
The firm has identified that an incorrect instruction for use (IFU) revision was included in the qualitative, multiplexed, nucleic acid-based in vitro diagnostic test kit.
Biofire Defense is recalling the FilmArray NGDS Warrior Panel (Ref: NGDS-ASY-0007) because an incorrect instruction for use was included in the test kit. This could lead to improper testing results if the kit is used without following the correct instructions.
The test kit contains an incorrect instruction for use that could result in improper testing results if the kit is used without following the correct instructions. This may lead to inaccurate diagnostic outcomes, but does not pose a direct physical hazard to users.
Healthcare professionals who use this in vitro diagnostic test kit for laboratory testing are most at risk. The recall affects specific lot numbers of the FilmArray NGDS Warrior Panel sold between 2018 and 2020.
Check the product label for the lot number and expiration date. Affected units include specific lot numbers listed in the recall notice, such as 457117D/2018-10-17 through 462819D/2020-06-10.
Look for the lot number and expiration date on the FilmArray NGDS Warrior Panel to determine if it is affected.
The product may have an incorrect instruction for use, which could lead to improper testing results. If you have the product, check the lot number to see if it is affected.
Check the product label for the lot number and expiration date. If it matches the affected lots listed in the recall, contact Biofire Defense for further instructions.
The affected products have specific lot numbers listed in the recall notice, such as 457117D/2018-10-17 through 462819D/2020-06-10. Check your product label for these details.
We’ve drafted a message you can send Biofire Defense to request your refund or repair — edit it as you like.
Subject: Recall Z-1448-2020 — Biofire Defense Biofire Defense Hello, I own a Biofire Defense that is covered by recall Z-1448-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
