FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Reported: October 15, 2025 Initiated: September 3, 2025 #Z-0106-2026
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.
Details
- Recalling Firm
- Inpeco S.A.
- Units Affected
- 8 units
- Distribution
- US distribution to CA & NY.
- Location
- Lugano
Frequently Asked Questions
What product was recalled? ▼
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic. Recalled by Inpeco S.A.. Units affected: 8 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 15, 2025. Severity: Moderate. Recall number: Z-0106-2026.
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