Inpeco S.A.
8 federal recalls on file, showing the 2 from the last 12 months. We monitor every CPSC, FDA, USDA, and NHTSA notice for Inpeco S.A. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-10-15FDA-DeviceClass IIFlexLab 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.
- 2025-10-15FDA-DeviceClass IIFlexLab (FLX) System. Potassium Test System. in vitro diagnostic
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.
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