Class 2 Device Recall FAST PBC Prep Cartridge and FAST System

• Date Initiated by Firm: November 02, 2022
• Date Posted: December 07, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0425-2023
• Recall Event ID: 91130
• Product Classification: Clinical sample concentrator - Product Code JJH
• 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.
• Code Information: TSP-UM-001, Revisions: 2 and 3; MKT-0025, Revisions: 2 and 3; TSP-PI-001, Revisions: 2 and 3
• FEI Number: 3013825847
• Recalling Firm/ Manufacturer: Qvella Corporation; 9133 Leslie St; Richmond Hill Canada
• Manufacturer 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.
• FDA Determined 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, TechSupport@qvella.com
• Quantity in Commerce: 1868
• Distribution: US: CA, NY, AL, UT
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.