Qvella Corporation: Medical Device Recall in 2022 - (Recall #: Z-0425-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 2, 2022

Date Posted: December 14, 2022

Recall Number: Z-0425-2023

Event ID: 91130

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.

Status: Ongoing

Product Quantity: 1868

Code Information:

TSP-UM-001, Revisions: 2 and 3; MKT-0025, Revisions: 2 and 3; TSP-PI-001, Revisions: 2 and 3

Distribution Pattern:

US: CA, NY, AL, UT

Voluntary or Mandated:

Voluntary: Firm initiated