Bracco has issued a short statement on the incident at AZ Sint-Blasius Dendermonde in East Flanders, Belgium, in which a single bottle of Iomeron 400 contrast agent contaminated with Klebsiella bacteria was the cause of eight patients becoming unwell after undergoing CT on 27 August.
“An independent external laboratory has completed the testing of the relevant unused samples of Iomeron 400 from the involved lots, retained at the manufacturing site, and/or returned by the AZ Sint-Blasius Hospital,” noted the statement. “The results of these third-party analyses confirmed the complete sterility of all the Iomeron 400 samples, demonstrating that no contamination occurred while manufacturing or distributing the product.”
Also, proactive monitoring of all the Belgian hospitals using samples from the same lots did not detect the occurrence of any similar adverse events, according to Bracco.
