Diagnostic Test Kits for GI Panel May Return False Negatives Due to Manufacturing Issue
BioFire FILMARRAY GI Panel diagnostic test kits may return false negative results due to a manufacturing event, potentially leading to missed diagnoses and inappropriate treatment. The affected kits were distributed to locations in 16 U.S. states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a diagnostic test that may produce false negative results, potentially leading to missed diagnoses and delayed care. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, placing this at severity 3 per the rubric criteria for risk-of-harm products without reported injury.
Plain-English summary
BioFire Diagnostics, LLC is recalling 53 kits of the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel, an in vitro diagnostic test system used to detect gastrointestinal pathogens. The product is a multiplexed nucleic acid-based test intended for use with BIOFIRE FILMARRAY Systems.
A manufacturing event may cause elevated rates of false negative results when using this diagnostic panel. False negatives could lead to missed infections, inappropriate treatment decisions, delays in treatment initiation, and false assurance to patients with actual infections. False negatives may also delay identification of disease outbreaks and result in additional transmission.
The affected kits were distributed to locations in 16 U.S. states: North Carolina, Missouri, Nebraska, Connecticut, Illinois, Tennessee, New Jersey, Ohio, Massachusetts, California, Florida, Utah, Iowa, Kansas, Texas, and Maryland. The affected lot numbers are 1749723 and 1746223, both with expiration date July 6, 2024.
The recalled product
- Product
- BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
- Manufacturer
- BioFire Diagnostics, LLC
- Hazard
- false-negative-results
- misdiagnosis
- treatment-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI-DI: 00815381020109. Kit Lot/Pouch Lot/Expiration: 1749723/2XKB23/July 6
- 2024
- 1746223/2XJA23/July 6
Distribution
Distributed in 16 states:
- CA
- CT
- FL
- IA
- IL
- KS
- MA
- MD
- MO
- NC
- NE
- NJ
- OH
- TN
- TX
- UT
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