Recall archive / FDA device enforcement
The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system ... — FDA record Z-0425-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 2, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Qvella Corporation
- Quantity
- 1868
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0425-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | TSP-UM-001, Revisions: 2 and 3; MKT-0025, Revisions: 2 and 3; TSP-PI-001, Revisions: 2 and 3 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: CA, NY, AL, UT
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 14, 2022
- Recall initiation date
- Nov 2, 2022
- Center classification date
- Dec 7, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.