# FDA recall Z-0106-2026

> **Inpeco S.A.** · Class II · device recall initiated 2025-09-03.

## Product

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

US distribution to CA & NY.

## Key facts

- **Recall number:** Z-0106-2026
- **Recalling firm:** Inpeco S.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-03
- **Report date:** 2025-10-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lugano, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0106-2026

## Citation

> AI Analytics. FDA recall Z-0106-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0106-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*