# FDA recall Z-1345-2022

> **Menarini Silicon Biosystems** · Class II · device recall initiated 2022-05-20.

## 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

## Reason for recall

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

## Distribution

CA FL IL IN MA MI NC NM NY OH ON PA TX  Foreign: Italy, Shanghai, Singapore,

## Key facts

- **Recall number:** Z-1345-2022
- **Recalling firm:** Menarini Silicon Biosystems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-05-20
- **Report date:** 2022-07-13

- **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-1345-2022

## Citation

> AI Analytics. FDA recall Z-1345-2022. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-1345-2022. Source: US FDA. Licensed CC0.

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