# FDA recall Z-3113-2017

> **Beckman Coulter Inc.** · Class II · device recall initiated 2017-06-26.

## Product

Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers  Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The purpose of the LH 700 Series is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies of any of these parameters. These studies might include further measurements of cell size and platelet distribution, manual WBC differential or any other definitive test that helps diagnose the patients condition. The purpose of the LH 500 Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and

## Reason for recall

Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.

## Distribution

Worldwide Distribution - US (nationwide) Internationally to Albania, Algeria, Andorra, Angola, Antigua and Barbuda, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Brazil, Bulgaria, Burundi, Canada, China, Colombia, Congo, Croatia, Czech republic, Ecuador, Egypt, Ethiopia, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, india, Indonesia, Italy, Japan, Iraq, Jordan. Kenya, Kuwait, Libya, Lithuania, Macau, Lebanon, Macedonia, Malawi, Malaysia, Mexico, Mongolia, Morocco, Mozambique, Netherlands, New Zealand, Nigeria, Pakistan, Panama, Paraguay, Philippines, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Swaziland, Sweden, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, UK, Uruguay, Venezuela, Vietnam, Virgin Islands, Yemen, Zambia, Zimbabwe.

## Key facts

- **Recall number:** Z-3113-2017
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-26
- **Report date:** 2017-09-13
- **Termination date:** 2023-09-14

- **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-3113-2017

## Citation

> AI Analytics. FDA recall Z-3113-2017. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-3113-2017. Source: US FDA. Licensed CC0.

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