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FDASeptember 3, 2025device

FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

inpeco

UPCs

07640172344002

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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