# FDA recall Z-2974-2020

> **Inpeco S.A.** · Class II · device recall initiated 2020-08-07.

## Product

Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

## Reason for recall

Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the  potential to mis-associate sample IDs leading to incorrect results or delayed results

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AK, FL, IA, LA, MA, MS, MT, NC, OH, TX, VA and the countries of AUSTRALIA, AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, NETHERLANDS.  NORWAY  SAUDI ARABIA  SOUTH KOREA  SWEDEN  UNITED ARAB EMIRATES

## Key facts

- **Recall number:** Z-2974-2020
- **Recalling firm:** Inpeco S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-08-07
- **Report date:** 2020-09-23
- **Termination date:** 2021-12-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lugano, N/A, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2974-2020

## Citation

> AI Analytics. FDA recall Z-2974-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2974-2020. Source: US FDA. Licensed CC0.

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