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 | Ongoing |
| Reason | High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples |
| Product | CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001 |
| Quantity | 484 units |
| Distribution | CA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore, |
| Initiated | 2022-05-20 |
| Classified | 2022-07-07 |
| Recall number | Z-1345-2022 |
| 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-1345-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90417/
Alerts for Menarini Silicon Biosystems Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.