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Lead Poisoning Testing Company Hit With FDA Warning Letter Over Inaccurate Blood Tests

Federal health officials indicate that a company selling blood lead testing kits committed several violations of federal law, resulting in the distribution of test kits that may provide inaccurate in results for children experiencing signs of lead blood poisoning

On October 23, the FDA sent a warning letter to Amy M. Winslow, president and chief executive officer of Magellan Diagnostics, Inc. The letter indicates that inspectors who visited a manufacturing facility in May and June found that the company had made several changes to its testing kits without notifying the agency. These changes, inspectors warn, may have made the tests inaccurate.

“The FDA has serious concerns about Magellan Diagnostics’ actions after learning about inaccuracies in results using its blood lead testing devices – tests that the American people depend on,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health, said in a press release. “The evidence uncovered during the inspection shows that the company put patients at risk after it recognized that its tests could provide inaccurate results and failed to take appropriate steps to report this issue and work through a strategy to effectively mitigate problems with the FDA.”

In July, Albert Gutierrez, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, announced that FDA investigators found a number of problems at a Magellan Diagnostics facility in North Billerica, Massachusetts, where the company manufactures LeadCare testing systems.

Those systems were linked to an FDA warning on May 17, which indicated that drawing blood from veins for the tests may not give accurate results. The warning applies to LeadCare Testing Systems by Magellan Diagnostics, Inc., including the LeadCare, LeadCare II, Lead Care Plus and LeadCare Ultra testing systems. They are used in clinics, laboratories, doctor’s offices and hospitals nationwide.

According to investigators, the company made changes to the testing kit without informing the agency or seeking approval for those changes, which could have affected the results of the tests.

“For example, the proposed labeling submitted to FDA as part of the premarket notification (510(k)) for the LeadCare II System at the time of the device’s clearance describes the readiness of the sample for analysis immediately after mixing of the treatment reagent with the blood sample. However, your firm made a significant change by adding to the device labeling an instruction that users allow the blood-treatment reagent mixture to stand for 4 hours at room temperature prior to analysis for venous blood samples that are shipped or rocked,” investigators wrote. “Your firm added this 4-hour incubation time to reduce the risk of the LeadCare II System underestimating lead values for these venous blood samples. This change could significantly affect the safety or effectiveness of the device and requires submission of a new 510(k).”

The inspectors also found that the facility did not meet current good manufacturing practice requirements, that some of the claims the company made about the tests were never actually tested to see if they were true, and that the manufacturer was aware of false test result problems before the LeadCare Ultra System was actually released for commercial distribution in September 2013.

The FDA gave Magellan 15 days from the date of the letter to respond, noting that the company’s previous responses to the agency’s concerns had been inadequate. Failure to do so could result in seizure of the company’s products, injunctions and civil monetary penalties, the FDA warned.

The FDA is recommending that health care professionals discontinue using the systems for venous blood samples, but says they can still be used to test blood drawn from capillary sources. The U.S. Centers for Disease Control and Prevention (CDC) are also recommending that parents of children younger than six, as well as pregnant or nursing mothers, who may be concerned about previous test results, should consult a health care professional about whether to have themselves or their child retested.

Elevated blood lead levels are an indicator that children may be at risk for side effects of lead poisoning, which can lead to serious nervous system injury, brain damage, seizures, growth or mental disability, as well as other severe health problems throughout the rest of their childhood and life.

One of the more common causes of of lead poisoning is lead-based paint, which was banned in the United States in 1978 due to the risk of severe and permanent brain damage and developmental problems, particularly in children. However, a number of older homes still contain the toxic paint on the walls, and if it flakes or peals off, young children could ingest the paint chips or breathe dust that comes from the paint, resulting in lead poisoning. Many of those homes are owned by HUD or receive HUD assistance.

In recent years, there has also been an increased focus on lead in drinking water, stemming from the recent and ongoing Flint water crisis, during which a change to the water system in the Michigan city resulted in high levels of lead in residents’ drinking water, causing thousands of children to suffer lead exposure and, potentially, lead poisoning.

The CDC estimates that 535,000 children ages 1-5, or about 2.6% of such children in the U.S., have levels of lead in their blood that place them at risk for adverse health effects. To come up with that number, the CDC analyzed data from the National Health and Nutrition Examination Survey from the years 1999 to 2002, and 2007 through 2010.

The majority of those children are poor and live in older urban areas, mainly in the inner city. Most are minorities, meaning such exposures add to numerous problems already plaguing inner city black and Latino youths, such as poverty, high crime and poor schools.

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