The FDA is warning that certain lead tests made by Magellan Diagnostics may yield inaccurate results. As a result, some children under 6, along with pregnant and nursing women, may need retesting, the Food and Drug Administration and Centers for Disease Control and Prevention said.
Specifically, the Agency is warning clinicians and patients that Magellan lead tests performed on blood drawn from a vein may provide data that are lower than the actual level of lead present in the blood.
And the FDA says it's aggressively investigating why these tests can give inaccurate results.
At this time, any of those tests performed with blood drawn from a finger or heel stick - which is how most lead tests are conducted in the USA - should be accurate.
Some laboratories offer other methods of lead testing and they are not believed to be affected at this time, the FDA noted.
The FDA's warning was issued for all four lead testing systems from Magellan Diagnostics including LeadCare, LeadCare II, LeadCare Plus and LeadCare Ultra. The warning only applies to tests in which blood samples were taken from a vein, not for the more common tests in which fingers or heels are pricked for a blood sample. The blood tests are used in laboratories and clinics throughout the USA, The Washington Post reports.
Lead poisoning is particularly risky to infants and young children, according to the U.S. CDC.
It also recommended that women, who are now pregnant or nursing and were tested in this manner while pregnant or nursing, get retested. But the majority of tests are unaffected, USA officials say. However, the agency says it does not have reason to believe the tests are inaccurate when done with capillary blood taken from a patients' finger or heel. The company stated that only 10 percent blood tests are carried out with blood drawn from the veins and accounts for about $1.8 million of Magellan Diagnostic's revenue. The company apologized for the interruption and promised they will "continue to work closely with the FDA to address the concerns identified with venous samples as quickly as possible". But if those levels are elevated, a follow up test is done with blood drawn from the arm. It can cause serious long-term health problems - even at low levels - including reduced intelligence, impaired hearing and irritability.
Lead exposure is risky: It can affect nearly every system in the body while producing no obvious symptoms, and as such, often goes unrecognized.
"If you had it done in a doctor's office, it's likely the Magellan test was used", said a spokeswoman. "It produces no obvious symptoms and can go undetected for years", Patrick Breysee, director of the CDC's National Center for Environmental Health, said during a conference call with reporters.
Children and infants are particularly vulnerable to the neurotoxic effects of lead poisoning. Whether diseases start at home or overseas, are curable or preventable, chronic or acute, stem from human error or deliberate attack, CDC is committed to respond to America's most pressing health challenges.