FDA warns of faulty lead tests

The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) on Wednesday warned that certain blood lead tests used in the country may be inaccurate.

Officials are recommending retesting for certain children, pregnant women and nursing mothers who did get tested using blood from a vein.

But Shuren said the investigation is still in its early stages and the agency has not determined the root cause of the inaccurate results.

The FDA's warning is based on now available data that indicate Magellan lead tests, when performed on blood drawn from a vein, may provide results that are lower than the actual level of lead in the blood.

Shuren said that the FDA first became aware of the issue during a review of a 510 (k) premarket submission for a new LeadCare product received from Magellan in March 2017.

"We have no evidence that Magellan's tests, when used with blood obtained from a finger or heel stick, are impacted", says Shuren. The blood tests are used in laboratories and clinics throughout the USA, The Washington Post reports.

The tests have been in use since 2014, the start of Flint's lead in water crisis, during which blood testing for adults and children concerned about lead exposure was routine.

FDA officials did not provide estimates of how many people may have been at risk for a faulty test.

It is unclear why Magellan lead tests perform differently with venous blood than with capillary blood from a finger or heel stick, FDA said.

Registered Nurse Brian Jones draws a blood sample from Grayling Stefek, 5, at the Eisenhower Elementary School, Tuesday, Jan. 26, 2016 in Flint, Mich. Although the majority of children tested were subject to a finger prick or a heel stick, a small percentage had blood drawn from a vein.

According to the FDA's statement, Magellan initially recognized the possible problem during the performance of their LeadCare Ultra -one of the trials- in August 2014 and they notified customers by letter on November 2014.

Doctors say pregnant and nursing women, as well as kids under the age of 6 should ask their doctors if they should be retested. It can cause serious long-term health problems - even at low levels - including reduced intelligence, impaired hearing and irritability. If such results find elevated lead levels, the results are confirmed through a venous blood test.

If you fall into any of those categories, the CDC recommends you talk to your doctor or another healthcare professional about whether or not you should be retested.

Lead exposure doesn't cause noticeable symptoms, however it can damage childrens' IQ.

Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said that the FDA investigation is now in its early phases, so most people are not likely to be affected.

Since a year ago, Reuters has identified more than 3,300 US neighborhood areas with documented childhood lead poisoning rates double those found in Flint, Michigan.


Popular
  • Debris found in Bermuda Triangle matches model of missing plane

    Debris found in Bermuda Triangle matches model of missing plane

    A number of aircraft and ships have disappeared under mysterious circumstances in the Bermuda Triangle over the years. A Coast Guard cutter was dispatched to the area and was expected to arrive later today to assist with the search.

    Heat land No. 14 pick in draft lottery

    With Kobe Bryant out of the picture and a new general manager in the fold, LA is a franchise in transition. And you never know when the next team is looking to rebuild and ship off a star player.

    Capitals' Game 6 win makes you wonder what Penguins have left

    They had a one-goal lead and 20 minutes standing between them and another Eastern Conference Finals appearance. There were just three players with a positive Corsi differential, according to http://naturalstattrick.com.
  • China's position on Kashmir 'unaffected' by CPEC

    China's position on Kashmir 'unaffected' by CPEC

    The president was among 29 heads of state and the representatives of 130 countries attending the two-day forum, which started on Sunday.

    Real Madrid to face Juventus in the UEFA Champions League final

    Carvalho played for Madrid between 2010 and 2013, and has since moved to Chinese side Shanghai SIPG after more than 90 games with AS Monaco.

    ITunes Coming to Windows App Store Ahead of Windows 10 S Launch

    But a year ago , the company conceded that the objective was unreachable under the self-imposed time limit. There is not much of a learning curve to adopt when it comes to using the app itself.
  • Iran Moderates Rally Round Rouhani to Oppose Hardliners

    Iran Moderates Rally Round Rouhani to Oppose Hardliners

    With Qalibaf dropping out , there are now five candidates contesting, though others may choose to drop out in the coming days. Mohammad Taghi Karroubi said the family was confident that the interior ministry would let his father vote on Friday.

    Ovechkin played through hamstring, knee injuries in playoffs

    The Senators did what they've done repeatedly during their surprising run to the NHL's final four: they found a way. I just said that we're gonna look at everything and try to get better so I'm not really thinking that [way].

    Chelsea's trip to West Brom sparks memories of Bolton in 2005

    Fabregas became the first player in the history of the Premiership who had 10 or more assists in 6 different seasons. Gary Cahill has insisted Chelsea are not getting complacent as they edge ever closer to the Premier League title.
  • Oubre gets Game 4 suspension for Olynyk spat

    The surges made Washington the first team to have two games with a run of 20-plus points in one postseason since the 2011 Spurs. Washington defended aggressively on Boston guard Isaiah Thomas , who scored 53 points in Tuesday's 129-119 overtime win.

    PH ready to take part in China's Silk Road initiative

    He warned that "isolation results in backwardness". - An additional US$14.5 billion to the Silk Road Fund. Some Belt and Road projects are raising concerns in certain countries.
    Fidget-spinner craze is sweeping the US

    Fidget-spinner craze is sweeping the US

    No one could predict the impact the fidget spinner has had on the toy industry in only a matter of months. As a teacher and a parent, I also recognize first-hand that kids learn differently.

CONNECT