Inpeco S.A. recalls FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the FDA, so its use may cause an increase in erroneous results or a delay in patient results.

Consignees received an Urgent Medical Device Recall notification via email dated 9/3/25. The notification instructs consignees to not rely on HIL functionality for clinical decision making or to flag potentially erroneous samples. HIL functionality must be discontinued and cannot be disabled by users. Inspeco must send an Inspeco Servicer to consignee locations to disable HIL functionality. Inspeco will contact consingnees to schedule this service. Consignees are to forward the provided notification to those whom it might concern. Consignees with questions can contact Regulatory Affairs via email at regulatory.affairs@inspeco.com or Inspeco Service Team via email at service.NA@inspeco.com.

• FDA enforcement recordOfficial FDA database entry for Z-0107-2026
• 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.