FDA Enforcement
Class II
Ongoing
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Recall: Z-0703-2024
·
Reported January 17, 2024
Enforcement
- Recall Number
- Z-0703-2024
- Event ID
- 93526
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- BioFire Diagnostics, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 17, 2024
- Initiation Date
- November 27, 2023
- Classification Date
- January 10, 2024
- Address
- 515 S Colorow Dr, Salt Lake City, UT, 84108-1248, United States
Description
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Reason
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.
Code Info
UDI-DI: 00815381020109. Kit Lot/Pouch Lot/Expiration: 1749723/2XKB23/July 6, 2024; 1746223/2XJA23/July 6, 2024
Distribution
US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
Quantity
53 Kits