THOR: Receives Warning Letter from FDA re Production Lots of...

THOR: Receives Warning Letter from FDA re Production Lots of ProTime Systems



By Fain Hughes, [email protected]



Thoratec Corporation (THOR) announced that its International Technidyne Corporation ("ITC") division received a Warning Letter from the FDA stating concerns about ITC's quality systems and specifically related to certain production lots of its ProTime System anticoagulation monitoring device. The Warning Letter relates to manufacturing and quality control issues involving a component from an outside supplier that could cause specific lots of the system to deliver error messages on the display instead of test results and/or the remote possibility of incorrect readings of patient blood coagulation levels.

Hopefully this doesn't impact on the Heartmate II....