# FDA recall Z-1530-2018

> **Menarini Silicon Biosystems** · Class II · device recall initiated 2018-04-04.

## 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.

## Reason for recall

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.

## Distribution

Worldwide Distribution - USA (nationwide) and to the countries of :  Canada and Italy

## Key facts

- **Recall number:** Z-1530-2018
- **Recalling firm:** Menarini Silicon Biosystems
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-04
- **Report date:** 2018-05-02
- **Termination date:** 2019-04-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Huntingdon Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1530-2018

## Citation

> AI Analytics. FDA recall Z-1530-2018. Retrieved 2026-06-13 from https://api.ai-analytics.org/recall/Z-1530-2018. Source: US FDA. Licensed CC0.

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