FDA Device recall Z-2406-2015
Cell Search Circulating Tumor Kit
- FDA Device
- Class II
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class II recall of Cell Search Circulating Tumor Kit by Veridex, citing 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 failu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2406-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-15 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Veridex |
| Distribution | US |
Product
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
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.
Identifiers
| code_info | Part Number 7900001, Kit Lot Number 0074B Exp Date 2015-10-08, Kit Lot Number 0094B Exp Date 2015-12-12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2406-2015%22
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