BioFire Diagnostics, LLC 2024-02-14 Health serious FDA
Health · FDA · Recall #FDA-Z-0993-2024
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only… Recall
Issued February 14, 2024 · BioFire Diagnostics, LLC
In February 2024, BioFire Diagnostics, LLC recalled the FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Their is a potential for false positive results when using Pneumonia panel.
What you should do
- 1 Stop using FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only… 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 14, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, M
- Recall number
- FDA-Z-0993-2024
- 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.