Qvella Corporation 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Qvella Corporation
Lot Codes / Batch Numbers
TSP-UM-001, Revisions: 2 and 3, MKT-0025, Revisions: 2 and 3, TSP-PI-001, Revisions: 2 and 3
Products Sold
TSP-UM-001, Revisions: 2 and 3; MKT-0025, Revisions: 2 and 3; TSP-PI-001, Revisions: 2 and 3
Qvella Corporation is recalling The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample pr due to Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and promotional materials are being correct. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, NY, UT
Page updated: Jan 10, 2026