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

FDA Device Recall #Z-0106-2026 — Class II — September 3, 2025

Recall Summary

Recall Number Z-0106-2026
Classification Class II — Moderate risk
Date Initiated September 3, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Inpeco S.A.
Location Lugano
Product Type Devices
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.

Lot / 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 from Inpeco S.A.

Recall # Classification Product Date
Z-0595-2026 Class II FlexLab (FLX); Version: FLX-217-10; Oct 30, 2025
Z-0596-2026 Class II FlexLab (FLX); Version: FLX-217-40; Oct 30, 2025
Z-0107-2026 Class II FlexLab X (FXX) System. Potassium Test System. ... Sep 3, 2025
Z-0560-2024 Class II Roche Cobas 8000 and Cobas PRO Interface Module... Nov 3, 2023
Z-1559-2023 Class II Input Output Module (IOM) FLX-201-Laboratory Au... Mar 10, 2023

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.