FDA Device recall Z-1345-2022
CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (…
- FDA Device
- Class II
- ongoing
- Published 2022-07-13
On 2022-07-13 the FDA classified a Class II recall of CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (… by Menarini Silicon Biosystems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1345-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-20 |
| Published | 2022-07-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Menarini Silicon Biosystems |
| Distribution | CA, FL, IL, IN, MA, MI, NC, NM, NY, OH, PA, TX |
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
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
Identifiers
| code_info | UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1345-2022%22
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