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Qvella Recalls

1 recall on record · December 14, 2022 to December 14, 2022 · Medical Devices

December 14, 2022Medical DevicesFDA

Qvella Corporation recalls The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for

Hazard: 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.

Qvella Recalls | RecallWatchUSA