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Qvella Corporation recalls The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for
Recalled December 14, 2022 · FDA recall Z-0425-2023 · Qvella
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. · FDA Class II
Units
1868
Sold at
US: CA, NY, AL, UT
Description
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.
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.
Manufacturer(s)
Qvella Corporation
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →