Cell Search Circulating Tumor Kit — Class II medical device recall Z-2406-2015
Terminated recall by Veridex, LLC, reported 2015-08-26, distributed nationwide. Complaints of the presence of artifacts that appears as small bead like structures in the image gallery when p
| Recall number | Z-2406-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Veridex, LLC, Raritan, NJ, United States |
| Recall initiated | 2015-05-15 |
| Classified | 2015-08-18 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 1,560 kits |
| Lot numbers | 0074B, 0094B |
| Model numbers | 7900001 |
| Expiration dates | 2015-10-08, 2015-12-12 |
Product
Cell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of epithelial origin in whole blood.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2406-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.