* FDA says co made unauthorized changes to device
* FDA says devices were misbranded
* Co sees no financial impact from FDA move (Updates alerts)
April 12 (Reuters) - U.S. health regulators have issued a warning letter to German healthcare conglomerate Fresenius SE for unauthorized design changes in its dialysis device, CombiSet, before its sale in the United States.
According to the U.S. Food and Drug Administration (FDA), the company's Fresenius Medical Care unit made some design changes to the device, including a change in the tubing segment from thick wall to thin wall.
The FDA said the company initiated a recall of the modified CombiSet on Nov. 19, 2010, due to device failure related to the design change.
The FDA said the modifications were not cleared under U.S. regulations and the devices were "adulterated" because there was no pre-market approval or an approved application for an investigational device exemption.
"These devices are also misbranded ... because you did not notify the agency of your intent to introduce these devices into commercial distribution," FDA told Fresenius in the warning letter.
A Fresenius Medical Care spokesman said the FDA warning letter on the device will have no financial impact on the company.
The company made the changes after it had voluntarily recalled the initial version of the CombiSet Tue Flow device in January, the spokesman said.
FDA has given 15 working days to respond and notify of the steps taken to correct the noted violations.
The FDA letter is available at:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm250691.htm (Reporting by Shravya Jain in Bangalore, additional reporting by Ludwig Burger in Frankfurt; Editing by Gopakumar Warrier)