FDA-Device2025-10-15Class II
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
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.
Sold states
US distribution to CA & NY.
Affected count
8 units
Manufactured in
Via San Gottardo 10, Lugano, Switzerland
Products
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0106-2026Want us to check the next one for you?
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