FDA Recalls BioFire Pneumonia Diagnostic Test Kits for Control Failures
BioFire Diagnostics recalls BIOFIRE FILMARRAY Pneumonia Panel plus test kits due to manufacturing defects that could lead to control failures and delayed test results. The affected kits were distributed in multiple US states and countries worldwide.
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 a Class II diagnostic device with a manufacturing defect creating risk of control failures and delayed results. The source describes a risk-of-harm scenario with no reported illnesses or injuries, which per the rubric qualifies as High severity.
Plain-English summary
BioFire Diagnostics, LLC is recalling BIOFIRE FILMARRAY Pneumonia Panel plus test kits (REF: RFIT-ASY-0143) due to a manufacturing process defect that increases the risk of control failures. These failures could result in delayed test results, potentially delaying diagnosis in patients undergoing pneumonia testing.
The affected units include lot number 2147723 (expiration 27-Aug-2024) and were distributed worldwide including the United States (West Virginia, Indiana, and Alabama), France, Italy, Spain, Greece, Japan, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, and Serbia. The U.S. Food and Drug Administration classified this recall as Class II.
Healthcare facilities that received affected kits should stop using them and contact BioFire Diagnostics, LLC for replacement or further instructions on how to proceed.
The recalled product
- Product
- BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 24
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 (1)
- UDI-DI: 00815381020314. Lot/Expiration: 2147723/27-Aug-2024
Distribution
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.
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