medical Class II Updated 2022-07-13

Menarini Silicon Biosystems recalls CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD inten

Recalled 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

Hazard / Issue

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

Issued by

FDA

Affected States: CA, FL, IL, IN, MA, MI, NC, NM, NY, OH, PA, TX
Lot/Code Info: UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022
View official government recall

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