# FDA recall Z-1074-2019

> **Abbott Laboratories** · Class II · device recall initiated 2019-02-20.

## Product

CELL-DYN Emerald analyzer, REF 09H39-01.     The CELL-DYN Emerald is an automated hematology analyzer intended for in-vitro diagnostic use in the clinical laboratory.

## Reason for recall

There is a potential for the device to generate Quality Control (QC) low or out-of-range low for parameters RBC and PLT.

## Distribution

Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bosnia and Herzegovina,  Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chile, China, Colombia, Congo, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gaza & Jericho, Germany, Greece, Guatemala, Guinea, Haiti,  Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mali, Mauritania, Mexico, Moldova, Montenegro, Mozambique, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, St. Maarten, St. Vincent & The Grenadin

## Key facts

- **Recall number:** Z-1074-2019
- **Recalling firm:** Abbott Laboratories
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-20
- **Report date:** 2019-04-10
- **Termination date:** 2021-08-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1074-2019

## Citation

> AI Analytics. FDA recall Z-1074-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1074-2019. Source: US FDA. Licensed CC0.

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