FDAFDA · Food and drugs·Recall number Z-2683-2024
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Published August 28, 2024 · Recall initiated: June 10, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- BioFire Diagnostics, LLC
- Distributor
- Worldwide - US Nationwide distribution in the states of WV, IN, AL and the countries of France, Italia, Spain, Greece, Japan Ltd, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, Serbia.
- Lot
- UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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