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Inpeco S.A. recalls FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Recalled October 15, 2025 · FDA recall Z-0106-2026 · Inpeco S.A
Hazard
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. · FDA Class II
Units
8 units
Sold at
US distribution to CA & NY.
Description
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.
Product
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Manufacturer(s)
Inpeco S.A.
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →