Bracco Diagnostics Inc. Resumes CardioGen-82 Shipments With New FDA-issued Box Warning Attached
Published: Feb 20, 2012
Bracco Diagnostics Inc. has resumed shipments of its recalled CardioGen-82 generators, which now come with new boxed warnings and quality control guidelines, the company told government officials at a conference Thursday afternoon. Further tests on the product have also confirmed previous reports that excess radiation levels found in two patients that triggered the voluntary recalls last summer were not indicative of manufacturing problems, the company said. The "patient incidents are isolated, site-related and not of a product manufacturing nature," said a Bracco slide shown at the public meeting with the U.S. Nuclear Regulatory Commission in Rockville, Md.