Recall Z-0106-2026— Inpeco S.A.
Class II · Ongoing
Class II FDA medical device recall by Inpeco S.A., initiated 2025-09-03. It names one FDA 510(k) clearance: K121012. Product: FlexLab (FLX) System. Potassium Test System. in vitro diagnostic. Reason: 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..
- Recalling firm
- Inpeco S.A.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-03
- Firm location
- Lugano, Switzerland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.