Class II

Medical Device Recall: FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

Inpeco S.A. · September 3, 2025

Reason for Recall

The FlexLab 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.

Distribution

US distribution to CA & NY.

States Affected

CA, NY

Quantity Affected

8 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0106-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Inpeco S.A. Medical Device Recall: FlexLab (FLX) System. Potassium Test System. in vitro diagnostic | SafeCheck