[pending] BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Pending LLM rewrite. Source: FDA_DEVICE Z-0602-2026.
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 unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
The recalled product
- Product
- BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- 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)
- UDI: 00815381020529 /Lot # 2649724
Distribution
Distributed nationwide across the United States.
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