Statement from Alberto Gutierrez, Ph.D., Director, Office Of In Vitro Diagnostics And Radiological Health, FDA's Center For Devices And Radiological Health On The Status Of FDA's Investigation Into Inaccurate Results From Certain Lead Tests
Published: Jul 17, 2017
SILVER SPRING, Md., July 13, 2017 /PRNewswire-USNewswire/ -- 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.
For more information:
FDA: Safety Issue on Magellan Diagnostics LeadCare Testing Systems
FDA: Form 483 Issued to Magellan Diagnostics
FDA: May 17 news release warning Americans about risk of inaccurate results from certain lead tests
CDC: Potential for Falsely Low Blood Lead Test Results from LeadCare Analyzers
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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SOURCE U.S. Food and Drug Administration