Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) Recalled by Inpeco S.A. Due to Firmware of the Sysmex XN-9000/XN-9100 Interface Module (IM)...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Inpeco S.A. directly.
Affected Products
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.
Quantity: 2 US and 6 OUS
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Inpeco S.A.
Inpeco S.A. has 33 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report