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.
- Recall Initiated
- August 7, 2020
- Terminated
- December 2, 2021
- Recall Number
- Z-2975-2020
- Quantity
- 10 US and 22 OUS
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
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
Root Cause
Software design
Action Taken
Inpeco issued Customer Letter dated August 7, 2020 forwarded to the customers either by Inpeco (for the laboratories where Inpeco is directly the distributor) or by the Inpeco distributors. Letter states reason for recall, health risk and action to take: customers impacted by the Field Action have to complete and return the Recall Letter Receipt Confirmation and Implementation Check form attached to the Customer letter within 15 days to Inpeco or the distributor. The customers impacted by the issue will be contacted by Inpeco or the distributors to arrange a visit to upgrade the impacted modules firmware. Contact reference person: Eva Balzarotti - Regulatory Affairs Manager. E-mail: Regulatory.Affairs@inpeco.com Phone: (+41) 919118 224