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news.Thoratec has announced that its International Technidyne division has received a warning letter from the FDA stating concerns about quality systems specifically related to certain production lots of its ProTime System anticoagulation monitoring device.
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The company said 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 the remote possibility of incorrect readings of patient blood coagulation levels.
International Technidyne is scheduled to meet with FDA to discuss the warning letter and its responses and believes that part of its corrective action will involve a voluntary recall of certain lots of its ProTime system, involving approximately 5,800 of the devices.
Management estimated that the cost of the product recall will be in the range of $0.5 million to $1 million.