CELLSEARCH Circulating Tumor Cell Kit Recalled for False Positive Risk
Menarini Silicon Biosystems is recalling CELLSEARCH Circulating Tumor Cell Kit due to potential false positive results in patient samples. The device may generate unassigned events that could affect diagnostic accuracy.
- 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
- Category
- Medical Device
- Distribution
- 12 states