FDA Device recall Z-0425-2023
The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacteria…
- FDA Device
- Class II
- ongoing
- Published 2022-12-14
On 2022-12-14 the FDA classified a Class II recall of The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacteria… by Qvella, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0425-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-11-02 |
| Published | 2022-12-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Qvella |
| Distribution | AL, CA, NY, UT |
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
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.
Identifiers
| code_info | TSP-UM-001, Revisions: 2 and 3; MKT-0025, Revisions: 2 and 3; TSP-PI-001, Revisions: 2 and 3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0425-2023%22
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