Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The FAST System and the FAST PBC Prep Cartridge together are a closed Recalled by Qvella Corporation Due to Device exceeds the limitations of a Class I...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Qvella Corporation directly.
Affected Products
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.
Quantity: 1868
Why Was This 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.
Where Was This Sold?
This product was distributed to 4 states: AL, CA, NY, UT
About Qvella Corporation
Qvella Corporation has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report