Home / Recalls / Inpeco S.A. / Z-0107-2026

Z-0107-2026 Class II Ongoing

Recalled by Inpeco S.A. — Lugano

Recall Details

Product Type
Devices
Report Date
October 15, 2025
Initiation Date
September 3, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

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 Pattern

US distribution to CA & NY.

Code Information

PN: FLX-056-40; UDI: 07640172344002: Serial No. FXX.0015.

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