Molecular Imaging News
November 19, 2005
Mallinckrodt Issues Voluntary Recall of Technetium Tc-99m Generators
On Nov. 18 Mallinckrodt issued a voluntary product recall on its Ultra-TechneKow(R) DTE generator (Technetium Tc-99m generator) with a request for immediate discontinuation of use of any of its generators in the market. This recall came as the result of a routine sterility assurance process revalidation.
This is an issue of great concern for the nuclear medicine community. It will affect many of our patients, necessitating rescheduling or alternative treatment for non-critical procedures. Mallinckrodt has indicated that patient doses should not be formulated from any of its generators and that generator availability will be affected for a minimum of six weeks. No adverse events related to the recall have been reported. SNM will work with Mallinckrodt in the coming days and weeks and offer our full support in any way possible.
Mallinckrodt has sent a letter to its customers accompanied by a question and answer sheet; click on the links below to access them.
As we learn more, we will keep you informed so we may continue to provide the best care for those who depend on our services. We will use e-mail and our Web site to communicate to you any further news or developments.
Peter S. Conti, M.D., Ph.D.
Valerie R. Cronin, CNMT, FSNMTS