CELLSEARCH¿ CIRCULATING Tumor Cell Kits — Class II medical device recall Z-1530-2018
Terminated recall by Menarini Silicon Biosystems, reported 2018-05-02, distributed nationwide. Unusually high number of total images/unassigned events may require additional time and effort for the operato
| Recall number | Z-1530-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Menarini Silicon Biosystems, Huntingdon Valley, PA, United States |
| Recall initiated | 2018-04-04 |
| Classified | 2018-04-26 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2019-04-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IT |
| Lot numbers | 2038, S038R, S038S, S038T, S038U, S038V, S038W |
Product
CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokeratins 8, 18+, and/or 19+) in whole blood.
Reason for recall
Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.
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-1530-2018. 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.