Recall Z-0425-2023 ยท JJH Clinical Sample Concentrator
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 cons
| Date | Dec 7, 2022 (initiated Nov 2, 2022) |
| Status | Open, Classified |
| 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 corrected to remove all references to downstream applications. |
| Root 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 | 1868 |
| Distribution | US: CA, NY, AL, UT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.