Z-0425-2023Class II

The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation...

Name: Z-0425-2023 The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation...
Creator: Qvella Corporation
Published: 2022-11-02
License: https://open.fda.gov/license/

Qvella Corporation / initiated 2022-11-02 / Open, Classified / root cause: labeling and UDI

FDA source

Qvella Corporation began a recall of The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly... on 2022-11-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0425-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-02
Posted: 2022-12-07
Recalling firm: Qvella Corporation
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.
Product code: JJH Clinical Sample Concentrator
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.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: On 11/02/22, recall notices were emailed to customers who were asked to discard all product labeling materials (i.e., user manual, instructions for use, product brochures, etc.) received to date from the recalling firm until new labeling materials are provided. Please respond to the email with the attached recall notice as follows "have read and understood the intended use and indications for use of FAST System and PBC Prep Cartridges." Customers with additional questions are asked to contact Technical Support at (833) 478-3552, [email protected]
Quantity in commerce: 1868
Distribution: US: CA, NY, AL, UT
Product codes and lots: TSP-UM-001, Revisions: 2 and 3; MKT-0025, Revisions: 2 and 3; TSP-PI-001, Revisions: 2 and 3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0425-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0425-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-12-14	2022-12-07

Product code JJH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)