---
title: "CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enume... — FDA record Z-1345-2022 | Is It on Recall"
description: "High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in som"
url: https://isitonrecall.com/recall/fda-device-z-1345-2022-cellsearch-circulating-tumor-cell-kit-epithelial-ivd-intended-for-the-enumeration-of-circulating-tum/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) ... — FDA record Z-1345-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 20, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: 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
- **Classification**: Class II
- **Recalling firm**: Menarini Silicon Biosystems
- **Quantity**: 484 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1345-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1345-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: (01)10888385000016(17)221004(10)S108 Lot Number: S108 Exp. Date: 04Oct2022 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New Mexico](https://isitonrecall.com/state/new-mexico/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Jul 13, 2022
- **Recall initiation date**: May 20, 2022
- **Center classification date**: Jul 7, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1345-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Menarini Silicon Biosystems records](https://isitonrecall.com/brand/menarini-silicon-biosystems/)