Inpeco S.A. recalls FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
- Recall date
- September 3, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0106-2026
- FDA classification
- Class II
- Brand / firm
- Inpeco S.A.
- Sold / distributed
- US distribution to CA & NY.
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
Get recall alerts
Free email alert whenever Inpeco S.A. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Inpeco S.A.