Recall Z-0587-2017 ยท CEM Electrode, Ion Specific, Potassium
Inpeco S.A.
FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.
| Date | Oct 4, 2016 |
| Status | Terminated |
| Reason | Inpeco received several notifications from the field about burnt schuko sockets. The customers reported that some smoke was seen coming from the damaged sockets. |
| Root cause | Employee error |
| Action | Inpeco sent an Urgent Field Safety Notice dated October 2016 for the Aptio Automation, the Accelerator a3600 and the FlexLab Shucko power cord cables to all affected US and foreign customers. The Urgent Field Safety Notice described the reason for the recalls and actions that should be taken. The firm is requesting all customers to complete and return the Field Correction Effectiveness Check form attached to the Urgent Field Safety Notice letter within 7 days. The Urgent Field Safety Notice letter should be forwarded to affected departments or consignees. To mitigate any possible risks to t |
| Quantity | 188 units |
| Distribution | Worldwide Distribution - US including Texas and New York. Foreign Consignees: Germany, Italy, France, Austria and Spain. |
| 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 |