Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module — Class II medical device recall Z-2974-2020
Terminated recall by Inpeco S.A., reported 2020-09-23, distributed nationwide. Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM) and of the Track to Rack Module has the potential
| Recall number | Z-2974-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inpeco S.A., Lugano, N/A, Switzerland |
| Recall initiated | 2020-08-07 |
| Classified | 2020-09-16 |
| Reported by FDA | 2020-09-23 |
| Terminated | 2021-12-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, DE, DK, FR, IT, JP, KR, NL, NO, SA, SE |
| Reason classes | software |
| Serial numbers | ACP.252, ACP.290, ACP.349, ACP.399, ACP.400, ACP.410, ACP.413, ACP.424 |
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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.