Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration Recalled by Menarini Silicon Biosystems Due to High number of total images/unassigned events including (dual...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Menarini Silicon Biosystems directly.
Affected Products
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
Quantity: 484 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed to 12 states: CA, FL, IL, IN, MA, MI, NM, NY, NC, OH, PA, TX
About Menarini Silicon Biosystems
Menarini Silicon Biosystems has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report