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

Recall date

November 2, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0425-2023

FDA classification

Class II

Brand / firm

Qvella Corporation

Sold / distributed

US: CA, NY, AL, UT

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 instrument isolate and concentrate bacterial cells directly from PBC by removing blood, cellular and culture media matrix components from the sample, thereby reducing the sample volume considerably while maintaining bacterial cell viability. The resulting material is a purified microbial suspension or Liquid Colony for use in downstream in vitro diagnostics.