Class II — Menarini Silicon Biosystems
| Recalling firm | Menarini Silicon Biosystems Inc. |
|---|---|
| Registered facility | Menarini Silicon Biosystems Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | N/A |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy |
| Initiated | 2018-04-04 |
| Classified | 2018-04-26 |
| Terminated | 2019-04-09 |
| Recall number | Z-1530-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Menarini Silicon Biosystems (Z-1530-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79872/
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