Inpeco S.A.: 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

Agency Publication Date: September 16, 2020

Affected Products

Product: FlexLab (FLX) 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 Laboratory Automation system - 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 perfor

Serial Numbers: US: FLX.0133 FLX.0181 OUS: FLX.0048 FLX.0049 FLX.0121 FLX.0155 FLX.0160 FLX.0200

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

Serial Numbers: US: ACP.413 ACP.424 OUS: ACP.349 ACP.399 ACP.400 ACP.410 ACP.252 ACP.290

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

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86263

Status: Resolved

Manufacturer: Inpeco S.A.

Manufactured In: Switzerland

Units Affected: 3 products (2 US and 6 OUS; 2 US and 6 OUS; 10 US and 22 OUS)

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Sources: FDA iRES · Raw API Response

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Affected Products

Serial Numbers: US: FLX.0133 FLX.0181 OUS: FLX.0048 FLX.0049 FLX.0121 FLX.0155 FLX.0160 FLX.0200

Serial Numbers: US: ACP.413 ACP.424 OUS: ACP.349 ACP.399 ACP.400 ACP.410 ACP.252 ACP.290