BioFire Diagnostics, LLC 2024-08-28 Health serious FDA
Health · FDA · Recall #FDA-Z-2683-2024
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 Recall
Issued August 28, 2024 · BioFire Diagnostics, LLC
In August 2024, BioFire Diagnostics, LLC recalled the BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer.
What you should do
- 1 Stop using BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 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
- August 28, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore,
- Recall number
- FDA-Z-2683-2024
- 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.