# FDA recall Z-2332-2021

> **Beckman Coulter Inc.** · Class II · device recall initiated 2021-07-15.

## Product

Normand Remisol Advance Data Manager, REF: C69412, C69413, C44703, and C57017 is a software device that interfaces between laboratory information systems (LIS) and laboratory instruments.

## Reason for recall

There is a potential that the data management system may add additional cells to the patient request which could lead to erroneous patient result.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of Al, CA, FL, GA, IL, IN, MA, NC, OH, PA, TN, TX and the countries of Australia, Belgium, Canada, China, Czech Republic, France, Italy, Netherlands, New Zealand, Poland, Russia, Switzerland, Taiwan, United Kingdom, United States, Zimbabwe.

## Key facts

- **Recall number:** Z-2332-2021
- **Recalling firm:** Beckman Coulter Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-15
- **Report date:** 2021-09-01
- **Termination date:** 2024-06-04

- **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-2332-2021

## Citation

> AI Analytics. FDA recall Z-2332-2021. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-2332-2021. Source: US FDA. Licensed CC0.

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