Tests for lead poisoning may be faulty, USA regulators warn

Certain tests to detect lead poisoning could produce faulty results, regulators warn

The FDA says blood lead tests manufactured by Magellan Diagnostics can give falsely-low results if they are used with blood drawn from a vein, as opposed to a finger or heel prick.

The Food and Drug Administration warned laboratories and healthcare professionals not to use any lead testing device made by Magellan Diagnostics, a company acquired by Meridian in 2016 for $66 million, to test blood drawn from veins.

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 agency is advising that lead tests using blood samples that are drawn from a vein should no longer be used.

The FDA believes the issue may date back to 2014 when the Flint water crisis began.

FDA cleared the first of Magellan's LeadCare diagnostics in 1997, and has cleared three subsequent versions-LeadCare II in 2005, LeadCare Ultra in 2013 and LeadCare Plus in 2015-for use in different settings. Some laboratories also offer other methods of lead testing, which are not believed to be affected.

Lead poisoning is hard to detect, but exposure to even small amounts of lead can result in serious health issues for children, who are at risk of developing "irreversible" brain damage and seizures, according to the Mayo Clinic.

You may need retesting yourself, too, if you're pregnant or nursing and also underwent this kind of test.

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

The FDA and the CDC recommended that children younger than six years old be retested if their Magellan venous tests showed lead levels at less than ten micrograms per deciliter. In Flint, Mich., for example, less than 1 percent of children tested for lead had blood samples taken from a vein, the officials said. "There is little evidence that Magellan tests using blood from a finger or heel stick are affected", Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said during a morning media briefing.

Lead exposure can affect almost every system in the body, produces no obvious symptoms, and frequently goes unrecognized, potentially leading to serious health issues. He said the company did not alert the FDA to the problem. Shuren added that while the Magellan LeadCare system is the only FDA-cleared test specifically for lead and the primary source of lead testing for doctor's offices and clinics in the US, it is "not the only method of testing", he said. While recommendations for lead screening differ from state to state, all states require children to be screened for lead exposure. But if those levels are elevated, a follow up test is done with blood drawn from the arm.

Lead exposure is risky: It can affect nearly every system in the body while producing no obvious symptoms, and as such, often goes unrecognized.

Children and infants are particularly vulnerable to the neurotoxic effects of lead poisoning.

Related News:

  • Trailer: First look at 'Star Trek: Discovery'

    Trailer: First look at 'Star Trek: Discovery'

    But a few wooden performances and editing that leaps wildly from scene to obviously unrelated scene does the trailer no favors. The image below showcases Captain Philippa Georgiou, played by Crouching Tiger Hidden Dragon star Michelle Yeoh , and Lt.
    France's Macron to unveil list of candidates for new party

    France's Macron to unveil list of candidates for new party

    During his election campaign, Macron had described Brexit as a "crime" that would deliver Britain to "servitude". The problem of opposition on the streets will be real and will have to be faced down.

    Snap stock plunges in U.S. following earnings report

    Wednesday was the first time Snap had to report its earnings after its IPO back in March, which valued the company at $28bn. After adjusting for the expected expenses, losses of $188.2 million were reported - greater than analysts anticipated.
  • Apple, Qualcomm spat intensifies, manufacturers drawn in

    Apple, Qualcomm spat intensifies, manufacturers drawn in

    It was just the royalties on Apple products that were not getting paid. "We are suing to get our money", Rosenberg said. A Qualcomm sign is pictured at one of its many campus buildings in San Diego, California, U.S.
    Google gets you info by pointing camera at it

    Google gets you info by pointing camera at it

    Many of Google's products are also vying against similar offerings from other tech conglomerates like Amazon and Microsoft. Google is developing a stand-alone virtual-reality headset — one that doesn't need a companion phone or personal computer.
    North Korea Could Be Linked To The WannaCry Cyberattack

    North Korea Could Be Linked To The WannaCry Cyberattack

    Cisco Systems closed up 2.3 per cent on Monday and was the second-biggest gainer in the Dow Jones Industrial Average. In China, 66 of the country's universities were affected by the global ransomware attack , authorities said.
  • Iran reformist drops out of election, supports Rouhani

    Iran reformist drops out of election, supports Rouhani

    During the previous presidential election in June 2013, Hassan Rouhani garnered 50.7 percent of a total of over 36 million votes. Washington cites Iran's missile program, its human rights record and support for terrorism.

    U.S., European Union to Discuss Airline Safety in Washington Next Week

    The agency has not said when it will implement the expanded ban, or released an outline of what the actual restrictions would be. As U.S. and European officials discuss aviation security in Brussels Wednesday , the airline industry is voicing major concerns.
    German leaders court migrants from Russia ahead of election

    German leaders court migrants from Russia ahead of election

    Alain Juppe, a former prime minister, called Philippe "a man of great talent" with "all the qualities to handle the hard job". Macron sought to bat away German fears on debt, saying he was opposed to mutualising "old debt" between eurozone countries.
  • Senate Intelligence Committee Wants to See Comey Memos

    Senate Intelligence Committee Wants to See Comey Memos

    Jason Chaffetz, R-Utah, on Wednesday said the committee planned to invite Comey to testify during a public hearing next week. She adds that "a special prosecutor is the first step, but it can not be the last".
    Brother of victim in unsolved Ohio massacre appears in court

    Brother of victim in unsolved Ohio massacre appears in court

    A witness has been charged with destruction of a Global Positioning System device as part of the investigation into those murders. Or it was in the "possession of another person with the intent to use the vehicle as a means of committing a crime".
    Mark Cuban admits Mavericks tanked at end of season

    Mark Cuban admits Mavericks tanked at end of season

    The headline on the Patrick radio show's own website read, Mark Cuban admits Mavs tanked this season. The NBA instituted the lottery the very next year.


Most liked

Rex had 8000-pound chomping power, study says
A study published Wednesday in the journal Scientific Reports reveals the power of the animal's bite. After ensuring that the crocodile 3D model was accurate, they built a similar one for T. rex .

Father of singers Nick and Aaron Carter dead
This is the second tragedy for the Carter family in recent years. "My heart is Completly shattered I'm in shock", he wrote". Nick Carter of the Backstreet Boys visits the Mix 106.1 Performance Theater on Sunday, Oct. 12, 2014, in Philadelphia.

Hamilton sees off Vettel in enthralling Barcelona battle
It meant that Hamilton would be on the quicker tyre after the second round of pit stops, allowing him to attack. Vettel was now in the chase for Hamilton who came in on lap 37 for new tires, followed shortly by Vettel.

Russia, Iran Bear Responsibility for Observance of Syria Safe Zones Agreement
Sergei Rudskoi of the Russian General Staff, speaks to the media in the Defense Ministry in Moscow, Russia, Friday, May 5, 2017. Weaponry and air strikes are to be banned within the zones - while no-fly zones will be introduced in the airspace overhead.

Abby Wambach and Glennon Doyle Melton
Former soccer star Abby Wambach and Christian blogger Glennon Doyle Melton celebrated Mother's Day with an intimate wedding. Trust me- you might just wake up one morning and find yourself smackdab in the middle of heaven.

The cleanest and dirtiest railway stations in India
The station notched up a score of 661.5 marks out of 1,000 while Visakhapatnam railway station secured 853.1 marks. Darbhanga railway station in Bihar was the dirtiest among the busiest stations, reported by ht.

ABC's 'The Little Mermaid' Live Musical Coming to TV in October
However, it looks like ABC is ready to give one of Disney classics the live-action treatment with a musical spin. The collaboration with Rolling Stone is the latest such joint venture between the publishing world and TV.

Trump Asked Comey to Shut Down Flynn Probe
According to the New York Times , Mr Comey wrote in the memo that Mr Trump told him Mr Flynn had done nothing wrong. Jon Tester of Montana and Claire McCaskill of Missouri reiterated the importance of getting the facts first.

Chelsea Manning released from military prison
Manning was sentenced to 35 years in jail. "People need to take responsibility for their actions". However, she apparently felt she owed it not only to herself but to the public as well.

Parents charged after infant girl suffers over 100 rat bites in Arkansas
In a bedroom, they found a blood-soaked infant toboggan, a baby blanket with blood, and a wooden cabinet with rodent droppings. Two teenage parents have been arrested after their newborn was taken to a hospital with "excessive rodent bites to its body".

WA wages growth lowest on record
Wage growth in the mining sector continues to decelerate with annual wage falling to 0.6 percent year-on-year. Inflation rose 0.5 per cent in the March quarter, lifting the annual rate to 2.1 per cent.

Healthy obesity a myth, study concludes
While there was an overall lower risk of peripheral vascular disease, healthy obese people who never smoked had an increased risk. To be classified as "metabolically healthy obese", individuals had to have none of the three metabolic abnormalities.

Will Trump Be Impeached? Online Bets Assess the Odds
I can understand Congressman's Greens's frustrations. "This is where I stand, I will not be moved". Green insisted that he did not consider politics while deciding to call for Trump's impeachment.

Fernandinho sees improvement during 'tough' season for Man City
Despite Man City's win over Leicester, Shaka Hislop feels Pep Guardiola must do a better job at managing games. West Ham and Inter Milan are reported to be interested in making a move for him.

James Rodriguez and Morata on target as Real Madrid steamrolls Granada
Zidane chose to rest his key players in the match against Granada as James Rodriguez and Alvaro Morata both scored a brace. He scored hat tricks in his last two Champions League games, and nine goals in his last five matches in all competitions.