Recall Z-2973-2020 ยท CEM Electrode, Ion Specific, Potassium
Inpeco S.A.
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 consolidate
| Date | Aug 7, 2020 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| Action | 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 modu |
| Quantity | 2 US and 6 OUS |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121012 | FLEXLAB 3.6, ACCELERATOR A3600 Inpeco S.P.A., Aug 31, 2012 |