Class 2 Device Recall FlexLab Aliquoter Module (mALX)

• Date Initiated by Firm: October 30, 2025
• Date Posted: November 26, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0595-2026
• Recall Event ID: 97887
• 510(K)Number: K121012
• Product Classification: Electrode, ion specific, potassium - Product Code CEM
• Product: FlexLab (FLX); Version: FLX-217-10
• Code Information: UDI-DI: 07640172340004 Serial number: FLX.0226
• Recalling Firm/ Manufacturer: Inpeco S.A.; Via San Gottardo 10; Lugano Switzerland
• Manufacturer Reason for Recall: 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.
• FDA Determined 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. Transmission of this Customer Letter: Until the service visit, please maintain awareness on this notice and apply the action recommended above. Please transfer this notice to whom it might concern. Please complete and return the Customer Letter Receipt Confirmation and Implementation Check form attached to this letter within 30 days directly to the email address specified in the email communication. If you have any questions, contact the Regulatory Affairs Department via email: regulatory.affairs@inpeco.com.
• Quantity in Commerce: 1 unit (OUS only)
• Distribution: US Domestic: MI. OUS International: Australia, Finland, France, Germany, Italy, Portugal, Spain, and UK.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CEM