Recall Z-0595-2026 ยท CEM Electrode, Ion Specific, Potassium
Inpeco S.A.
FlexLab (FLX); Version: FLX-217-10;
| Date | Nov 26, 2025 (initiated Oct 30, 2025) |
| Status | Open, Classified |
| Reason | The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes. |
| Root cause | Device Design |
| Action | On October 30, 2025, "Urgent: Medical Device Correction" letters were sent to customers. Action to be taken: To avoid the occurrence of the described issue Inpeco recommends removing all the secondary sample tubes in the printer tubes buffer (red arrow) each time the printer cover (blue arrow) is opened for error recoveries and for preventive maintenance procedures. Your service provider will contact you to schedule the service visit to implement the corrective actions which include the installation of a new sensor, the software and firmware upgrade, and the operations manual update. Transmi |
| Quantity | 1 unit (OUS only) |
| Distribution | US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK. |
| 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 |