FDANovember 2, 2022device
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...
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
qvella
Recall history
No related federal recalls on record for this brand yet.
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