FAST Sample Preparation System Labeling Corrected for Regulatory Scope
Qvella is correcting documentation for the FAST System, a blood culture sample preparation device, because it exceeded its original regulatory scope. The company is updating manuals and promotional materials to clarify approved applications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II medical device recall focused on documentation and labeling correction to align promotional materials and instructions with the device's regulatory scope. No illnesses, injuries, or hospitalizations have been reported.
Plain-English summary
Qvella Corporation is correcting labeling and documentation for the FAST System and FAST PBC Prep Cartridge, a medical device used to isolate and concentrate bacterial cells from positive blood cultures for downstream diagnostic testing. The device exceeded the limitations of its original Class I 510(k)-exempt regulatory scope, and the manufacturer is updating user manuals, instructions for use, and promotional materials to remove references to applications outside the device's approved scope.
Approximately 1,868 units have been distributed in California, New York, Alabama, and Utah. This is a precautionary corrective action to ensure the device's labeling and documentation comply with its authorized regulatory scope.
Users with affected devices should contact Qvella Corporation for corrected documentation and guidance on the device's approved applications.
The recalled product
- 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…
- Manufacturer
- Qvella Corporation
- Affected units
- 1,868
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- TSP-UM-001
- Revisions: 2 and 3
- MKT-0025
- TSP-PI-001
Distribution
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