On May 17, the U.S. Food and Drug Administration warned Americans that Magellan Diagnostics’ LeadCare test systems performed on blood drawn from the vein (venous) may provide inaccurate results.
At that time, our first priority was to warn laboratories, health care professionals and people who may have been impacted by this issue. We also launched an aggressive investigation to determine the cause of the inaccurate results and promised to continue to communicate as we learned more about the issue.
As part of our investigation, we inspected Magellan Diagnostics’ facility in North Billerica, Massachusetts. Today, we are releasing the report issued at the conclusion of the inspection, which includes several inspectional observations that may be violations of federal law. We are carefully reviewing the evidence collected during the inspection to determine if there have been violations of federal law and whether further action is warranted.
The FDA takes these observations and the risks these tests may have posed to patients very seriously and continues to encourage people to follow the FDA’s and Centers for Disease Control and Prevention’s recommendations from May 17.
As we continue our investigation into the cause of the inaccurate results, the FDA will continue to provide updates on our findings and any changes to our recommendations.