Z-2682-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2024
- Initiation Date
- June 10, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 58
Product Description
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
Reason for Recall
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.
Distribution Pattern
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.
Code Information
UDI-DI: 00815381020178. Lot/Expiration: 2147623/28-Aug-2024, 2147523/27-Aug-2024