AKSYS WARNING LETTER ADDS TO COMPANY'S TROUBLES

The FDA sent personal hemodialysis (PHD) system maker Aksys a June 8 warning letter saying that its devices were adulterated and misbranded because the company changed its recommendation for how long patients should use the system without requesting premarket approval. The letter was posted on the FDA website June 27.

The FDA said the PHD -- the firm's primary product -- is no longer in compliance with Aksys' earlier 510(k) premarket application. Patients with kidney failure use the PHD system at home. Before altering its recommendation for how long the product should be used, the company should have filed a new 510(k) application.

The company said it is reviewing its changes to the PHD system and its new system use recommendations.

"Aksys is committed to working cooperatively and expeditiously with the FDA and is undertaking a review of other modifications made to the PHD System," the Lincolnshire, Ill.-based firm said in a release. (http://www.fdanews.com/ddl/33_29/)