FDA recall Z-0107-2026

Inpeco S.A. · Class II · device

Product

FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

Reason for recall

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.

Distribution

US distribution to CA & NY.

Key facts

Status: Ongoing
Initiation date: 2025-09-03
Report date: 2025-10-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lugano, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0107-2026