The FAST System and the FAST PBC Prep Cartridge recall
The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells…
Why was The FAST System and the FAST PBC Prep Cartridge recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
TSP-UM-001, Revisions: 2 and 3; MKT-0025, Revisions: 2 and 3; TSP-PI-001, Revisions: 2 and 3
- Product
- The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells…
- Recalling firm
- Qvella Corporation
- Quantity
- 1868
- Distribution
- US: CA, NY, AL, UT
- Recall date
- December 14, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)