Recall Z-0425-2023— Qvella Corporation

Name: FDA recall Z-0425-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-02

Class II · Ongoing

Class II FDA medical device recall by Qvella Corporation, initiated 2022-11-02. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. 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..

Recalling firm: Qvella Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-11-02
Firm location: Richmond Hill, N/A, Canada

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.