Menarini Silicon Biosystems Recalls CellSearch Circulating Tumor Cell Kits
Menarini Silicon Biosystems is recalling CellSearch Circulating Tumor Cell Kits because unusually high image counts may delay result reporting.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a delay in reporting results rather than a direct physical injury or acute health risk, fitting the criteria for a moderate severity recall.
Plain-English summary
Menarini Silicon Biosystems is recalling CellSearch Circulating Tumor Cell Kits (IVD), Product Code 7900001. The recall involves specific lots identified by UDI codes and serial numbers S038R through S038W, with a note that 0 units were distributed to the field.
The recall was initiated because an unusually high number of total images or unassigned events may require additional time and effort for the operator to review all images. This issue may cause a delay in reporting the results.
The product is distributed worldwide, including the United States (nationwide), Canada, and Italy. Users should contact the manufacturer for further instructions regarding the affected lots.
The recalled product
- 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.
- Manufacturer
- Menarini Silicon Biosystems
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch
Distribution
Distributed nationwide across the United States.
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