Aksys receives FDA warning letter about dialysis machine


LINCOLNSHIRE, Ill.--Aksys Ltd. has received a warning letter from the U.S. Food and Drug Administration about it's marketing of the Personal Hemodialysis System, according to a June 20 company release.

The June 8 letter said Aksys marketed its PHD System with a modified dialysis treatment length that exceeded the treatment length originally cleared by the FDA in March 2002, according to Aksys.

Aksys added that it was "committed to working cooperatively and expeditiously with the FDA to resolve the matters raised in the FDA letter." The home dialysis company also said it will review other modifications made to the PHD System since 2002.

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