The FAST System and the FAST PBC Prep Cartridge together are a closed — Class II medical device recall Z-0425-2023
Ongoing recall by Qvella Corporation, reported 2022-12-14, distributed in AL, CA, NY, UT. Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and
| Recall number | Z-0425-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qvella Corporation, Richmond Hill, N/A, Canada |
| Recall initiated | 2022-11-02 |
| Classified | 2022-12-07 |
| Reported by FDA | 2022-12-14 |
| Distributed | AL, CA, NY, UT |
| Quantity | 1,868 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0425-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.