WEDNESDAY, May 17, 2017 (HealthDay News) - Lead tests made by Magellan Diagnostics may yield inaccurate results for some children and adults, USA health officials warned Wednesday. CDC is recommending that parents of children younger than aged 6 years, and pregnant women and nursing mothers who have been tested for lead exposure talk to a health care professional about whether retesting is indicated.
Currently, the FDA believes the issue may date back to 2014, the agency said, adding that Wednesday's warning is for all four of Magellan Diagnostics' lead testing systems: LeadCare, LeadCare II, LeadCare Plus and LeadCare Ultra. The FDA says the company's tests shouldn't be used for those kinds of blood samples.
FDA estimates that about 8 million blood lead tests have been performed using the Magellan systems since the beginning of 2014.
The tests, manufactured by Magellan Diagnostics, are commonly used in doctors' offices and clinics, and on its website the company calls itself "the most trusted name in lead testing".
Neither are there problems with other blood tests used to detect lead, which account for about half the total, he said.
If you have had your child tested for lead exposure, the St. Louis City Health Department wants you to be aware of some new concerns about the results you may have received. The FDA along with the Centers for Disease Control and Prevention urged the population to retest children, pregnant and breastfeeding women who tested their blood with the faulty test.
The agency "did not feel that the data was either adequate regarding what they thought may have been the cause of the problem, the extent of the problem or the effectiveness of the mitigation they put in place", the FDA's Shuren said. Low-level lead exposure, even at blood lead concentrations below 5 g/dL, can increase the risk of intellectual and academic disabilities in children, and is linked to higher rates of behavioral disorders such as hyperactivity and attention deficits, and lower birth weight. However, most of the tests were conducted with blood drawn from the capillary and not the vein.
Patrick Breysse, director of the CDC's National Center for Environmental Health, said, "We understand that parents of children and others affected by this problem will be concerned about what this means for their health". If such results find elevated lead levels, the results are confirmed through a venous blood test.
Lead exposure is unsafe: It can affect nearly every system in the body while producing no obvious symptoms, and as such, often goes unrecognized.
Lead poisoning is especially risky to babies and young children.
Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said the investigation was in its early stages, and that most people probably won't be affected.