The Recall Desk

Manufacturer

Menarini Silicon Biosystems

2 recalls in our database name Menarini Silicon Biosystems as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2022-07-13

Of the 2 recalls from Menarini Silicon Biosystems we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-1345-2022·2022-07-13

    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
  • ModerateFDA (Devices)·Z-1530-2018·2018-05-02

    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.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Menarini Silicon Biosystems

business

Country
Italy

Source: Wikidata (Q112085344), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.