Inpeco S.A.: FlexLab (FLX) System. Potassium Test System. in vitro diagnostic

Hazard

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 from the source

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. Quantity: 8 units Lot/code info: PN: FLX-056-01, FLX-056-11; UDI: 07640172340004: Serial No. FLX.0204, FLX.0205, FLX.0209, FLX.0210, FLX.0216, FLX.0220, FLX.0221, FLX.0222.

UPC codes

07640172340004

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.