Device product
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
Z-2406-2015
Product summary
- Firm
- Veridex, LLC
- Event
- Event 71673
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1560 kits
- Official record key
device-enforcement:Z-2406-2015
Official wording
Reason: 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.
Code information: Part Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08, Kit Lot Number 0094B Exp Date 2015-12-12
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.