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Lower Respiratory Microbial Nucleic Acid Detection System

FDA product code QBH · Class 2 · Microbiology

6
Registered devices
0
Adverse events
4
Recalls
2
510(k) clearances

Devices with this code

Unyvero — Curetis GmbHUnyvero — Curetis GmbHUnyvero — Curetis GmbHUnyvero — Curetis GmbHUnyvero — Curetis GmbHUnyvero — Curetis GmbH

Recent recalls

DateFirmReason
2023-12-14BioFire Diagnostics, LLCTheir is a potential for false positive results when using Pneumonia panel.
2023-05-08BioFire Diagnostics, LLCDue to manufacturing issue, panels may result in false negative results.
2021-06-07BioFire Diagnostics, LLCDue to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame.
2021-04-16BioFire Diagnostics, LLCElevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.