Tests for lead poisoning may be faulty, US regulators warn

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

As NBC News reports, many children and pregnant women may need to get new lead tests because one of the most common lab tests may have given falsely low readings, the Food and Drug Administration said Wednesday.

"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", Jeffrey Shuren, the director of the FDA Center for Devices and Radiological Health, said in the statement.

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 is concerned that Magellan lead tests that use blood drawn from a vein may provide results that are lower than the actual level of lead in the blood".

The FDA and CDC revealed that Magellan Diagnostics manufactured the faulty lead tests that are under scrutiny.

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. The company makes the only lead test used in doctor offices and clinics and that test uses blood from finger or heel sticks.

Eden Wells, chief medical executive of MDHHS, said that while less than 2 percent of the lead tests performed in the state were performed with these devices using a venous blood sample, his department is taking the issue very seriously.

"While most children likely received an accurate test result, it is important to identify those whose exposure was missed, or underestimated, so that they can receive proper care", Patrick Breysse, director of the CDC's National Center for Environmental Health, said in a statement. They added that now pregnant women and nursing mothers who had a venous blood draw with this system should also be re-tested.

Shuren says testing should be re-done in kids under 6 years of age who had a blood test result of 10 micrograms per deciliter or less.

Shuren said that since the beginning of 2014, they estimate that 8 million tests were used with the Magellan system, but "the majority were for capillary blood". He added that the agencies are looking into potential causes (such as the type of tubes or chemicals used during processing), and to "confirm there is no problem with the capillary blood test". The agency discovered that the company "significantly underestimated" the amount of risk to the public, and lacked "adequate data and supporting documentation regarding the cause of the problem and effectiveness of mitigation". But if those levels are elevated, a follow up test is done with blood drawn from the arm.

Lead exposure can affect almost every system in the body, produces no obvious symptoms, and frequently goes unrecognized, potentially leading to serious health issues.

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

The U.S. Centers for Disease Control and Prevention has more on lead.

Related News:

  • Australia plans major spending plus surplus in 3 years

    Australia plans major spending plus surplus in 3 years

    Uni students will pay more for tertiary education with a 2.5 per cent efficiency dividend introduced. The jobless rate is set to ease from 5.75 per cent this year to 5.25 per cent in 2020/21.
    Garland has no interest in leaving judiciary for FBI, source says

    Garland has no interest in leaving judiciary for FBI, source says

    Comey, for instance, was a former United States Attorney in Manhattan before being appointed deputy attorney general by George W. Cornyn told the AP he has not had any further conversations about it with the administration since Saturday.
    Search for missing plane on the Bermuda Triangle continues

    Search for missing plane on the Bermuda Triangle continues

    Ms Blumin and her former husband James Ramsey had just put their Tribeca loft on the market for $US3.7 million ($A5 million). Ulrich is a licensed pilot, who also served as a Coast Guard Auxiliary pilot at air station Cape Cod.
  • He's in very good nick - Zidane delighted with Ronaldo

    He's in very good nick - Zidane delighted with Ronaldo

    We [Celta] feel very strong and know what to expect from a great side who are fit and coming off a great week. It was the flawless goal for the occasion, and epitomised the inhuman goal-scoring instinct of Ronaldo.
    Rust, Schultz, Hornqvist Out For Penguins For Game 3 Vs Sens

    Rust, Schultz, Hornqvist Out For Penguins For Game 3 Vs Sens

    The Penguins just hope that's possible if any of the Rust, Hornqvist, and Schultz trio are unable to draw into the lineup. Streit was on the team's top power-play unit during the morning skate and might make his 2017 Stanley Cup Playoffs debut.
    Activists say Kurdish-led forces advance on IS-held Raqqa

    Activists say Kurdish-led forces advance on IS-held Raqqa

    The U.S. military uses the Incirlik Air Base in southern Turkey for attacks on IS positions in neighboring Syria . This order needs to be assessed in the context that for the better part of two-and-a-half years, U.S.
  • Has the Queen given her blessing to Prince Harry and Meghan Markle?

    Has the Queen given her blessing to Prince Harry and Meghan Markle?

    Prince Harry and Meghan Markle would be able to marry at Westminster Abbey, if they were to Wednesday , despite being a divorcee. If things weren't real before, they are definitely real now! Is an engagement on the cards for Prince Harry and Meghan Markle?

    Jury to hear closing arguments in Oklahoma officer's trial

    But prosecutors said in arrest filings that Shelby "reacted unreasonably by escalating the situation" into a fatal encounter. As she turned around to walk to her patrol vehicle , she noticed Crutcher walking towards her, she testified.

    McCain says Trump's problems are 'reaching Watergate size'

    Trump met with Comey in the Oval Office and told him: "I hope you can see your way clear to letting this go, to letting Flynn go". He has previously written about film for Bloody Disgusting , We Got This Covered , What Culture , and The Celebrity Cafe .
  • Always Dreaming shows his pre-Derby edge

    That leaves Term of Art as the only California-based horse in what is expected to be a 10-horse Preakness field. Royal Mo was pulled up by jockey Gary Stevens and was found to have a fractured sesamoid in his right foreleg.
    Man United set to re-sign Keane for £25m

    Man United set to re-sign Keane for £25m

    Keane's clause entitles United to 25 per cent of any sell-on fee, meaning United will pay less for Keane than any of their rivals. Manchester United have emerged as the front-runners in the race to sign the 24-year-old who left Old Trafford for £2m.
    Japan's Abe reaffirms conviction that TPP benefits Asia-Pacific

    Japan's Abe reaffirms conviction that TPP benefits Asia-Pacific

    He is in Tokyo for talks with Japanese Prime Minister Shinzo Abe. New Zealand would preferences on how the text could be better.


Most liked

Advanced Micro Devices' (AMD) Outperform Rating Reiterated at Wells Fargo & Co
The semiconductor manufacturer reported ($0.04) EPS for the quarter, hitting the Thomson Reuters' consensus estimate of ($0.04). In related news, CFO Devinder Kumar sold 94,199 shares of the business's stock in a transaction on Wednesday, May 3rd.

Gay men get caning for sex in Indonesia
To do so constitutes khalwat, directly translated as "seclusion" and punishable by public caning. "The prosecution is very harsh". A sentence recommendation is a usual step in an Indonesian court case and is typically followed soon afterwards by a verdict.

Four Reasons The Red Sox Will Be Just Fine (With GIFs)
The Cardinals have given up nine runs in their last three games and three or less runs in six of their last 12 games. Boston's only other trip to an NL ballpark this season was a three-game series in Milwaukee earlier this month.

Former Liverpool player Dirk Kuyt retires after helping Feyenoord to Dutch title
Kuyt, 36, netted a hat-trick on Sunday to secure a first national championship for the Rotterdam club in 18 years. Our captain Dirk @Kuyt has just announced his retirement from football.