The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for
Summary
The FDA issued a Class II for The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and by Qvella Corporation. 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 correct.
Details
Source
Device Recall
External ID
Z-0425-2023
Action Date
2022-12-14
Status
Ongoing
Category
device
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.
Lot/Code Info: TSP-UM-001, Revisions: 2 and 3; MKT-0025, Revisions: 2 and 3; TSP-PI-001, Revisions: 2 and 3
Quantity Affected: 1868
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.
Distribution
US: CA, NY, AL, UT
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-02
Company
Richmond Hill, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 176 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Qvella Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Qvella Corporation have FDA actions?
This is the only FDA action we have on record for Qvella Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0425-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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