# FDA recall Z-3101-2017

> **Beckman Coulter Inc.** · Class II · device recall initiated 2017-06-20.

## Product

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2.    The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm.    Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.

## Reason for recall

The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.

## Distribution

Worldwide Distribution - USA (nationwide) Distribution to the states of :  AL, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and  WV., and to the countries of  : Australia, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Greece, Hong Kong, India, Israel, Italy, Japan, Morocco, Portugal, South Korea, South Africa, Spain, Taiwan, Turkey, United Kingdom, Vietnam, and  Switzerland.

## Key facts

- **Recall number:** Z-3101-2017
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-20
- **Report date:** 2017-09-06
- **Termination date:** 2021-04-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3101-2017

## Citation

> AI Analytics. FDA recall Z-3101-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-3101-2017. Source: US FDA. Licensed CC0.

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