BioFire Diagnostics, LLC: BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MD Quantity: 53 Kits Lot/code info: UDI-DI: 00815381020109. Kit Lot/Pouch Lot/Expiration: 1749723/2XKB23/July 6, 2024; 1746223/2XJA23/July 6, 2024

UPC codes

00815381020109

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.