Home / Recalls / Inpeco S.A. / Z-0106-2026

Z-0106-2026 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
8 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

US distribution to CA & NY.

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.

Other recalls by Inpeco S.A.

  • Z-0595-2026 Class II — FlexLab (FLX); Version: FLX-217-10; (October 30, 2025)
  • Z-0596-2026 Class II — FlexLab (FLX); Version: FLX-217-40; (October 30, 2025)
  • Z-0107-2026 Class II — FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic (September 3, 2025)
  • Z-0560-2024 Class II — Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation (November 3, 2023)
  • Z-1559-2023 Class II — Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of (March 10, 2023)
  • Z-1561-2023 Class II — PVT Interface Module (PVT)-Laboratory Automation system Brand names of the sa (March 10, 2023)
  • Z-1560-2023 Class II — Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names o (March 10, 2023)
  • Z-1563-2023 Class II — Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of (March 10, 2023)
  • Z-1562-2023 Class II — Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand na (March 10, 2023)
  • Z-0087-2022 Class II — FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand (September 10, 2021)