Skip to content
Recall Observatory FDA recall evidence

Device product

FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

Z-0106-2026

September 03, 2025

Class II

Product summary

Firm
Inpeco S.A.
Event
Event 97565
Status
Ongoing
Classification
Class II
Quantity
8 units
Official record key
device-enforcement:Z-0106-2026

Official wording

Reason: 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.

Code information: PN: FLX-056-01, FLX-056-11; UDI: 07640172340004: Serial No. FLX.0204, FLX.0205, FLX.0209, FLX.0210, FLX.0216, FLX.0220, FLX.0221, FLX.0222.

Distribution pattern: US distribution to CA & NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.