Covidien said its Ultra TechneKow DTE Generator (technetium Tc-99m generator) has a post-marketing quality control issue for its Sodium Pertechnetate Tc-99m solution, related to its molybdenum Mo 99 concentration level.
Per the package labeling, the expiration time of the radioisotope is “no later than 12 hours after elution and each eluate of the generator should contain no more than the USP limit of 0.15 microcuries molybdenum Mo 99 per millicurie technetium Tc 99m per administered does at the time of administration.”
Coviden said it was notified by customers that the concentration of molybdenum Mo 99 to technetium Tc 99m does not meet the 12 hour expiration time as stated on the labeling.
“To ensure there are no safety or health issues, we urge you to follow the Covidien package labeling and USP guidelines for the Ultra-TechneKow DTE Generator,” Covidien said.
Covidien said it has been working with customers to resolve the issue, and is communicating regularly with the FDA and NRC to update the agencies on its efforts.
“We have sent letters and a Frequently Asked Questions document to all Covidien technetium Tc 99m generator customers as a reminder that package insert procedures should always be followed,” Joanna Schooler, public relations, Imaging Solutions and Pharmaceuticals, Covidien, told Health Imaging News. “We also have included the notification with our generator shipments this week.”
“It is important that customers consistently follow the package labeling for the Ultra-Technekow DTE Generator to ensure that each eluate of the generator meets the required concentration of molybdenum Mo 99 to technetium Tc 99m,” she added.
The lot numbers affected are: 8005, 8007, 8008, 8009, 8010, 8011, 8012 and 8013, Covidien said.