Meridian Bioscience Inc. released comments on a recent Food and Drug Administration Safety Notification concerning Magellan Diagnostics.
Meridian Bioscience commented on May 17 and June 6 relating to the FDA and Magellan relations concerning a venous blood lead testing that took place before Meridian acquired Magellan. On June 29, the FDA completed its inspection into the operations of Magellan.
Magellan has taken a further step, in seeking to clarify confusion:
1. the testing in question only relates to samples of venous blood collection tubes, which is only 10 percent of the testing that Magellan systems carried out.
2. The FDA has cleared LeadCare Blood Lead Testing System for use with capillary blood samples.
"Magellan’s access to extensive dialogue with the FDA during its inspection provided valuable insight that, coupled with the help of Meridian’s regulatory team, will assist us in our response to the observations," Magellan President and CEO Amy Winslow said.
Both Magellan and Meridian are working with the FDA and Centers for Disease Control to clear up any miscommunication from here on out.