Risk of inaccurate results LeadCare testing systems by Magellan Diagnostics

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The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States” FDA (2017).

The FDA report “The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.

The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan. We are conducting studies with the CDC to identify the cause and better characterize the extent of the problem. At this time, the FDA has no evidence that Magellan’s LeadCare Testing Systems have the same problem when processing capillary blood samples. The FDA is aggressively investigating the root cause of this issue with the manufacturers, health care facilities and the CDC, and will update this safety communication as critical information becomes available.

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