# FDA recall Z-2184-2018

> **Cellavision AB** · Class II · device recall initiated 2017-12-04.

## Product

CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60    Product Usage:  The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The devices are intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells

## Reason for recall

A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.

## Distribution

US Nationwide in the states of FL, IL, NY, and NC

## Key facts

- **Recall number:** Z-2184-2018
- **Recalling firm:** Cellavision AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-12-04
- **Report date:** 2018-06-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lund, N/A, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2184-2018

## Citation

> AI Analytics. FDA recall Z-2184-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-2184-2018. Source: US FDA. Licensed CC0.

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