BIOFIRE FILMARRAY Pneumonia Panel Recalled for Manufacturing Defect
BioFire Diagnostics is recalling 58 units of BIOFIRE FILMARRAY Pneumonia Panel due to a manufacturing defect that increases the risk of control failures and delayed test results.
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 FDA Class II recall involves a manufacturing defect affecting diagnostic test control, creating a risk of delayed test results in pneumonia diagnosis. No illnesses or injuries are reported, making this a theoretical risk-of-harm scenario that meets the High criterion for products where injury has not yet been reported.
Plain-English summary
BioFire Diagnostics, LLC is recalling the BIOFIRE FILMARRAY Pneumonia Panel (REF: RFIT-ASY-0144) due to a manufacturing process defect. The affected product comprises 58 units distributed worldwide, including the US states of West Virginia, Indiana, and Alabama, as well as France, Italy, Spain, Greece, Japan, Singapore, Chile, Taiwan, Israel, Romania, Ecuador, and Serbia.
The manufacturing defect creates an increased risk of control failures in the pneumonia panel. Control failures could lead to delayed test results, which may impact timely clinical decision-making and patient care.
Healthcare facilities and laboratories that received this product should verify whether they have units bearing lot numbers 2147623 (expiration 28-Aug-2024) or 2147523 (expiration 27-Aug-2024). Contact BioFire Diagnostics for instructions regarding affected units in your facility.
The recalled product
- Product
- BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144
- Manufacturer
- BioFire Diagnostics, LLC
- Hazard
- control-failure
- diagnostic-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 (2)
- UDI-DI: 00815381020178. Lot/Expiration: 2147623/28-Aug-2024
- 2147523/27-Aug-2024
Distribution
Distributed nationwide across the United States.
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