BioFire Diagnostics, LLC 2024-01-17 Health serious FDA
Health · FDA · Recall #FDA-Z-0704-2024
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test… Recall
Issued January 17, 2024 · BioFire Diagnostics, LLC
In January 2024, BioFire Diagnostics, LLC recalled the The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of treatment, and may provide false assurance to someone with a true infection, delayed identification of an outbreak, and may result in additional transmission.
What you should do
- 1 Stop using The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid 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
- January 17, 2024
- Units affected
- Not reported
- Sold at
- US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
- Recall number
- FDA-Z-0704-2024
- 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.