FDA Device recall Z-1530-2018
CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration…
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumeration… by Menarini Silicon Biosystems, citing 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 res….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1530-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-04 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Menarini Silicon Biosystems |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI (01)10888385000012(17)180810(10)S038 (01)10888385000012(17)180810(10) (01)10888385000012(17)180810(10)S038S (01…UDI (01)10888385000012(17)180810(10)S038 (01)10888385000012(17)180810(10) (01)10888385000012(17)180810(10)S038S (01)10888385000012(17)180810(10)S038T (01)10888385000012(17)180810(10)S038U (01)10888385000012(17)180810(10)S038 V Serial, Batch, Lot # 2038 S038R S038S S038T S038U S038V S038W (0 distributed to the field) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1530-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.