# FDA recall Z-0516-2020

> **Beckman Coulter, Inc.** · Class II · device recall initiated 2019-10-07.

## Product

UniCel DxH Slidemaker Stainer (DxH SMS) and UniCel DxH Slidemaker Stainer II (DxH SMS II) - Product Usage: The intended use is as follows: The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

## Reason for recall

When the UniCel DxH Slidemaker Stainer and UniCel DxH Slidemaker Stainer II dispense probe is slightly bent, there is a potential for cell carryover from the previous sample, and erroneous results could be reported from the slide review.  Erroneous results may be reported from the laboratory which may trigger unnecessary or inappropriate patient treatment.

## Distribution

Worldwide distribution - US Nationwide distribution and countries of Australia, Bahrain, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Egypt, Ethiopia, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Morocco, Netherlands, New Zealand, Philippines, Portugal, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Vietnam.

## Key facts

- **Recall number:** Z-0516-2020
- **Recalling firm:** Beckman Coulter, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-07
- **Report date:** 2019-12-04
- **Termination date:** 2021-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2020

## Citation

> AI Analytics. FDA recall Z-0516-2020. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-0516-2020. Source: US FDA. Licensed CC0.

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