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INACCURATE LEAD TESTING KITS

In the News: INACCURATE LEAD TESTING KITS May 18, 2017

The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are warning Americans that some Lead testing systems may provide inaccurate results.

The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) warning that all four of Magellan Diagnostics’ lead testing systems: LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra may provide inaccurate results. According to a Saftey Warning issued by both agencies, the Magellan Diagnostics’ lead testing systems have been producing a test with falsely low results when blood drawn from a vein is used for testing.

Lead exposure and poisoning can be harmful especially to children six years and younger, pregnant women and nursing mothers. Lead is naturally occurring substance, but it can have toxic effects on humans and animals, and most human exposure to lead comes from human activity. Lead and lead dust can be found in the air we breathe and the water we drink. Through the years, lead has been used in a variety of products, and it has been released into our atmosphere as a result of burning fossil fuels and as it is used in industrial manufacturing process.

Lead can affect almost every organ in the body, and the side effects of exposure can vary. Children are the most susceptible to the effects of lead. While all adults should avoid lead exposure, it is even more paramount for pregnant women and nursing mothers, because lead present in the bloodstream can be passed along to a developing fetus or to a nursing child. Experts warn that children exposed to lead, even low levels can be affected. Some possible results of lead exposure are:

• Behavior and learning problems
• Lower IQ and Hyperactivity
• Slowed growth
• Hearing Problems
• Anemia

Lead exposure can have lasting impacts, and therefore it is important for healthcare providers to monitor lead exposure, especially in high-risk populations. Due to the concerns related to lead exposure patients and physicians need to be able to depend on the accuracy of the medical test that checks the levels of lead in the bloodstream.

This FDA and CDC’s response to the inaccuracy of the Magellan Diagnostics’ lead testing kits is a testament to the importance of monitoring at-risk populations for lead exposure. Representatives from both the FDA and CDC have voiced their concerns about the issues.

In a statement Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health stated that “The FDA is deeply concerned by this situation and is warning laboratories and health care professionals that they should not use any Magellan Diagnostics’ lead tests with blood drawn from a vein.” He went on to say that the “agency is aggressively investigating this complicated issue to determine the cause of the inaccurate results and working with the CDC and other public health partners to address the problem as quickly as possible.”

The CDC is recommending that children younger than six years (72 months) of age, women who are currently pregnant or nursing, at the time of this alert (May 17, 2017) be retested if their test was conducted using blood drawn from a vein using any Magellan Diagnostics’ LeadCare System tests. Any other children and adults that have been tested for lead exposure and are concerned about the accuracy of their results should contact their healthcare provider’s to discuss the potential need for retesting.

For more information about Children and Lead, click the link below to review the CDC Fact Sheet: Blood Lead Levels in Children

https://www.cdc.gov/nceh/lead/ACCLPP/Lead_Levels_in_Children_Fact_Sheet.pdf

To read the FDA Press Release visit https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm558769.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery