Device product
FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
Z-0107-2026
Product summary
- Firm
- Inpeco S.A.
- Event
- Event 97565
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0107-2026
Official wording
Reason: The FlexLab X 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.
Code information: PN: FLX-056-40; UDI: 07640172344002: Serial No. FXX.0015.
Distribution pattern: US distribution to CA & NY.
Derived failure modes
-
Unknown
The FlexLab X 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.