Tyco unit recalls isotope generator

Hazelwood, MO-based Mallinckrodt, a division of Tyco International Healthcare, initiated a voluntary recall of its Ultra-TechneKow DTE generators (technetium Tc-99m generators) manufactured on or after Feb. 23, 2007.

The recall is due to a single questionable sample identified during routine sterility assurance testing of a recent generator production run.

The generator provides a closed system for the production of sterile technetium Tc-99m, a radioactive isotope used for medical diagnostic tests and research.

Mallinckrodt, a unit of Tyco International Healthcare, said the recall is effective immediately, and manufacturing of these products has been suspended until at least early April to allow sufficient time for the production process to be revalidated.