FDA Enforcement
Class II
Ongoing
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Recall: Z-2683-2024
·
Reported August 28, 2024
Enforcement
- Recall Number
- Z-2683-2024
- Event ID
- 94942
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- BioFire Diagnostics, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 28, 2024
- Initiation Date
- June 10, 2024
- Classification Date
- August 16, 2024
- Address
- 515 S Colorow Dr, Salt Lake City, UT, 84108-1248, United States
Description
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
Reason
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.
Code Info
UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024
Distribution
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.
Quantity
24 Kits