# FDA recall Z-0091-2018

> **Beckman Coulter Inc.** · Class II · device recall initiated 2017-10-02.

## Product

AQUIOS CL Flow Cytometer, Catalog No. B30166, Rx.   The firm name on the label is Beckman Coulter Ireland Inc., Ireland.    The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping. It is used in conjunction with the following reagents and software package: AQUIOS Tetra-1 Panel monoclonal antibody reagents, AQUIOS Tetra-2+ Panel monoclonal antibody reagents, and AQUIOS CL Flow Cytometry Software.

## Reason for recall

The system may duplicate sample requests leading to sample misidentification when connected to a Laboratory Information System (LIS)

## Distribution

Worldwide Distribution - US Distribution to the states of :  AZ, CA, CO, FL, GA, IL, IN, KS, NC, NY, OR, PA, SC, TX, and WA, including  Puerto Rico and government distribution, and to the countries of : Canada, Angola, Australia, Belgium, Botswana, Brazil, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Uganda, Ukraine, United Kingdom, and Zambia.

## Key facts

- **Recall number:** Z-0091-2018
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-02
- **Report date:** 2017-11-22
- **Termination date:** 2019-05-08

- **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-0091-2018

## Citation

> AI Analytics. FDA recall Z-0091-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0091-2018. Source: US FDA. Licensed CC0.

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