medical Class II Updated 2020-09-23

Inpeco S.A. recalls Aptio Automation systems with Sysmex XN-9000/XN-9100 Interfa

Recalled Product

Aptio Automation systems 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers: US: AP2.0111 AP2.0137 AP2.0190 AP2.0191 AP2.0290 AP2.0296 AP2.0321 AP2.0322 AP2.0349 AP2.0385 AP2.0398 OUS: AP2.0111 AP2.0113 AP2.0143 AP2.0170 AP2.0225 AP2.0242 AP2.0250 AP2.0259 AP2.0265 AP2.0270 AP2.0285 AP2.0295 AP2.0316 AP2.0350 AP2.0382 AP2.0388 AP2.0389 AP2.0390 AP2.0392 AP2.0448 APT.0058 APT.0065
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