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Nov 7 (Reuters) - Thoratec Corp (THOR.O: Quote, Profile, Research) said it may recall about 5,800 ProTime System anticoagulation monitoring devices as its ITC division received a warning letter from U.S. health regulators stating concerns about its quality systems.
The ProTime System monitors clotting activity in blood in patients on anticoagulant therapy.
The cardiovascular device maker said the warning letter relates to manufacturing and quality control issues involving a component from an outside supplier.
The product recall will cost $0.5 million to $1.0 million, but this will have no impact on its fiscal 2007 outlook, the company said. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Vinu Pilakkott)
The ProTime System monitors clotting activity in blood in patients on anticoagulant therapy.
The cardiovascular device maker said the warning letter relates to manufacturing and quality control issues involving a component from an outside supplier.
The product recall will cost $0.5 million to $1.0 million, but this will have no impact on its fiscal 2007 outlook, the company said. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Vinu Pilakkott)