Agency classClass IIOur severity:High FDA (Devices)·Z-0703-2024·Announced 2024-01-17

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — In Vitro Diagnostic
Hazard: false-negative-results
misdiagnosis
treatment-delay
Affected units: 53

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:

Part of a larger recall action

This product is one of 2 recalled by BioFire Diagnostics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · BioFire Diagnostics, LLC

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Same hazard · false negative results