BioFire Diagnostics, LLC 2024-02-21 Health serious FDA
Health · FDA · Recall #FDA-Z-1140-2024
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test… Recall
Issued February 21, 2024 · BioFire Diagnostics, LLC
In February 2024, BioFire Diagnostics, LLC recalled the FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
What you should do
- 1 Stop using FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact BioFire Diagnostics, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- BioFire Diagnostics, LLC
- Category
- Health
- Recall date
- February 21, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA,
- Recall number
- FDA-Z-1140-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- BioFire Diagnostics, LLC has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.