Device product
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
Z-0703-2024
Product summary
- Event
- Event 93526
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 53 Kits
- Official record key
device-enforcement:Z-0703-2024
Official wording
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 information: UDI-DI: 00815381020109. Kit Lot/Pouch Lot/Expiration: 1749723/2XKB23/July 6, 2024; 1746223/2XJA23/July 6, 2024
Distribution pattern: US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD
Derived failure modes
-
Unknown
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.