Aksys receives FDA warning letter

By Elaine Rigoli

Tampa, Fla., June 20 - Aksys, Ltd. has received a warning letter from the Food and Drug Administration regarding the company's marketing of the Personal Hemodialysis system with a modified treatment length that exceeds the treatment length provided in the company's premarket 510(k) notification for the system.

Aksys said it will cooperate with the FDA to resolve the matters raised in the letter and is undertaking a review of other modifications made to the PHD system since March 2002, when it received premarket notification, in light of this letter.

Aksys, based in Lincolnshire, Ill., produces hemodialysis products for patients suffering from kidney failure.

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