# FDA recall Z-3135-2017

> **Beckman Coulter Inc.** · Class II · device recall initiated 2017-08-21.

## Product

AQUIOS CL Flow Cytometer System    The AQUIOS CL Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping.

## Reason for recall

Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.

## Distribution

Worldwide Distribution: United States (nationwide) and countries of: Angola, Australia, Botswana, Canada, Chile, Columbia, Ghana, Israel, Malaysia, Namibia, Pakistan, Panama, South Africa, Uganda, France, Switzerland, Poland, Portugal, Germany, Belgium, Finland, Czech Republic, Denmark, Netherland, Turkey, Spain, Great Britain, Romania, Brazil, Italy, Sweden, Ghana, Colombia, Lesotho and Zambia

## Key facts

- **Recall number:** Z-3135-2017
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-21
- **Report date:** 2017-09-27
- **Termination date:** 2023-09-27

- **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-3135-2017

## Citation

> AI Analytics. FDA recall Z-3135-2017. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-3135-2017. Source: US FDA. Licensed CC0.

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