Richmond Hill, N/A, Canada
Qvella Corporation recalls
1 recall recorded since 2018, most recently on 2 November 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 2 November 2022
- Reason
- Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and promotional materials are being corrected to remove all references to downstream applications.
- Distribution
- US: CA, NY, AL, UT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0425-2023
- The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly from a positive blood culture (PBC). The cartridge and instrumen
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.