[pending] BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
Pending LLM rewrite. Source: FDA_DEVICE Z-1877-2025.
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: Pending LLM scoring against the rubric.
Plain-English summary
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results.
The recalled product
- Product
- BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems
- Manufacturer
- BioFire Diagnostics, LLC
- Category
- Medical Device — Devices
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)
- Lot# 1475424/ UDI: None
Distribution
Distribution scope not specified by the agency.
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