Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ Recalled by Menarini Silicon Biosystems Due to Unusually high number of total images/unassigned events may...
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 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.
Quantity: N/A
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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