Respiratory test panels recalled over elevated risk of false negative results
BioFire Diagnostics is recalling 23 kits of the BioFire Respiratory Panel 2.1 because unintended movement of pouch chemistry may cause false negative results and control failures.
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: Scored 3 under the risk-of-harm criterion: an elevated false negative rate can leave an infection undetected, and no injuries are reported.
Plain-English summary
The BioFire Respiratory Panel 2.1, an in vitro diagnostic supplied as a 30-test kit, REF 423742, is being recalled.
Due to unintended movement of pouch chemistry, the nucleic acid test may result in an elevated risk of false negative results and a risk of control failures.
The recall covers 23 kits, totalling 690 pouches, carrying UDI 00815381020529, from lot 2649724. The product was distributed in Idaho, Oregon and Arizona. The FDA has classified the action as Class II.
A false negative on a respiratory panel can leave an infection undetected. The enforcement record reports no injuries. Laboratories holding the affected lot should stop using it and follow BioFire's instructions.
The recalled product
- Product
- BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
- Manufacturer
- BioFire Diagnostics, LLC
- Category
- Medical Device — Diagnostic test
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 Expanded Lot#: 1471725
Distribution
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