CELLSEARCH Circulating Tumor Cell Kit — Class II medical device recall Z-1345-2022
Ongoing recall by Menarini Silicon Biosystems, reported 2022-07-13, distributed in CA, FL, IL, IN, MA, MI, NC, NM…. High number of total images/unassigned events including (dual positives) and the potential for false positive
| Recall number | Z-1345-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Menarini Silicon Biosystems, Huntingdon Valley, PA, United States |
| Recall initiated | 2022-05-20 |
| Classified | 2022-07-07 |
| Reported by FDA | 2022-07-13 |
| Distributed | CA, FL, IL, IN, MA, MI, NC, NM, NY, OH, PA, TX |
| Countries outside the US | IT, SG |
| Quantity | 484 units |
| UPC / GTIN / UDI-DI | 10888385000016 |
| Lot numbers | S108 |
| Model numbers | 7900001 |
| Expiration dates | 2022-10-04 |
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
Reason for recall
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
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-1345-2022. 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.