# FDA recall Z-0472-2019

> **Beckman Coulter Inc.** · Class I · device recall initiated 2018-01-12.

## Product

COULTER EPICS XL Flow Cytometer  COULTER EPICS XL-MCL Flow Cytometer  SYSTEM II Software

## Reason for recall

A manufacturing defect on the amplifier board of the Flow Cytometers my cause signal loss and/or signal drifting resulting in absence of data or a population shift in the data plots.  This can impact patient results for any application.

## Distribution

Worldwide distribution.  US Nationwide including Puerto Rico.    OUS:  FC 500:  Japan, South Korea, China, Italy, Spain, United Kingdom, Germany, Bangladesh, Czech Republic, France, Pakistan, India, South Africa, Austria, Saudi Arabia, Algeria, Turkey, Belgium, Netherlands, Bulgaria, Sweden, Australia, Hungary, Sri Lanka, Uruguay, Canada, New Zealand, Switzerland, Gabon, Portugal, Mexico, Singapore, Monaco, Hong Kong, Guadeloupe, Zambia, United Arab Emirates, Ireland, Reunion, Poland, Egypt, Slovakia, Croatia, Brazil, Chile, Bahrain, Slovenia, Bosnia and Herzegovina, Greece, Myanmar, Morocco, Serbia, Philippines, Lebanon, Romania, Moldova, Qatar, Barbados, Iraq, Oman, Namibia, Indonesia, Thailand, The Bahamas, Macau, El Salvador, Panama, Denmark, Venezuela, Azerbaijan, Israel, Colombia, Peru, Malaysia, Vietnam, Tunisia, Kuwait, Kenya, Libya, Latvia, Russia, Belarus, Ukraine, Kazakhstan, Taiwan    EPICS XL:  Albania, Algeria, Angola, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, 

## Key facts

- **Recall number:** Z-0472-2019
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-12
- **Report date:** 2018-11-28
- **Termination date:** 2024-04-30

- **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-0472-2019

## Citation

> AI Analytics. FDA recall Z-0472-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0472-2019. Source: US FDA. Licensed CC0.

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