Inpeco S.A. recalls FlexLab (FLX)

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.

FlexLab (FLX); Version: FLX-217-10;

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.

• FDA enforcement recordOfficial FDA database entry for Z-0595-2026
• FDA 510(k) clearance · K121012The device's official FDA premarket clearance record
• FDA device classification · CEMOfficial FDA classification for this device type
• CFR regulation · 21 CFR 862.1600The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Inpeco S.A.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.