Reported Dec 14, 2022 · Ongoing
The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system…
Qvella Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Qvella Corporation · 9133 Leslie St · Richmond Hill, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- TSP-UM-001
- Revisions
2 and 3MKT-0025
- Revisions
2 and 3TSP-PI-001
- Revisions2 and 3
- Amount recalled
- 1868
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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