Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in
FDA device recall Z-2406-2015 · posted 2015-08-18 · Terminated
Recall details
- Recalling firm
- Veridex, LLC
- Reason for recall
- Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when processing both control cells and patient samples as well as the failure of high control cells.
- Action taken
- Janssen Diagnostics, LLC sent a urgent product correction notification/customer confirmation of receipt on 5/15/2015 via Fed Ex.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- NQI
- Quantity affected
- 1560 kits
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-05-15
- Date posted
- 2015-08-18
- Date terminated
- 2016-03-30
- Location
- Raritan, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 (K103502) | Veridex, LLC | 2010-12-21 |