# FDA recall Z-0235-2018

> **Normand Informatique** · Class II · device recall initiated 2017-10-16.

## Product

Remisol Advance Software (Driver Architect) Catalog Number B32129    The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing and data management (i.e. archiving and restoration of patient results). The Remisol Advance system also offers workstation consolidation to three Beckman Coulter instruments from a single user console.

## Reason for recall

Beckman Coulter has identified that due to a software nonconformity in connection with a changed service setting Remisol could display wrong results.

## Distribution

Worldwide Distribution - US Distribution  and to the countries of  : Australia, France, Germany, Israel and  Russia

## Key facts

- **Recall number:** Z-0235-2018
- **Recalling firm:** Normand Informatique
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-16
- **Report date:** 2017-12-20
- **Termination date:** 2024-02-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Arras CEDEX, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0235-2018

## Citation

> AI Analytics. FDA recall Z-0235-2018. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-0235-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*