Magellan Diagnostics Recalls Lead Testing Systems That May Give Inaccurate Results

Magellan Diagnostics has recalled its LeadCare Testing Systems because the devices may underestimate blood lead levels and give inaccurate results when processing venous blood samples. Falsely lower test results may lead to improper treatment for lead exposure or poisoning.

The recalled Magellan testing devices were manufactured from September 2013 to now, and were distributed nationwide from September 2014 to the present. More than one million devices have been recalled.

Lead Exposure—No Safe Level

According to the Centers for Disease Control and Prevention (CDC), at least four million U.S. households have children that are exposed to high levels of lead. Lead poisoning is particularly dangerous to infants and young children because their bodies may absorb more lead than adults’ bodies do, and their brains and nervous systems are more vulnerable to the damaging effects of lead. Lead poisoning often occurs with no obvious symptoms, and therefore it frequently goes unrecognized until the health problems are severe.

Children, typically, are exposed to lead from drinking water from corroding plumbing, and from inhaling or ingesting dust from lead-based paint. Lead can also be transmitted through breast milk.

Parker Waichman notes that many inner city children have multiple lead exposure risks, because so many live in older, less-well-maintained buildings where lead pipes and lead paint may be present.

The CDC warns that there is no scientifically accepted safe blood lead level: even a small amount of lead can cause lasting problems for a child. Lead exposure can lead to irreversible problems including lower IQ, learning difficulties, and behavioral problems. Flint, Michigan is dealing with widespread lead poisoning because of the lead contamination of the city’s water. In many cities, older water systems and lead pipes in older buildings—including schools—expose residents to dangerous levels of lead. The Environmental Protection Agency (EPA) recommends that lead in drinking water should be below 15 parts per billion.

The city of Flint, Michigan is still struggling with a drinking water crisis that began in 2013 when the city switched its water source in an effort to save money. But when the highly corrosive Flint River water was introduced into the city’s water system, it corroded the city’s iron water mains, turning the water brown and exposing residents to lead. CNN reports that the water was not being treated with an anti-corrosive agent, as required by federal law.

In late 2015, Flint switched back to Lake Huron water, but lead levels are still unacceptable and scores of residents, in particular children, has experienced health problems from drinking, cooking with, and bathing in the contaminated water.

Residents are pressing the state to assume the cost of replacing the city’s old pipes—Flint’s mayor says this could cost up to $1.5 billion. Residents also want a fund set up to cover the health and developmental impact on children.

The results of lead exposure cannot be reversed and many Flint children will need medical and educational support services for many years to come.

Importance of Accurate Lead Testing

Accurate blood level lead test results are important for protecting people, especially children, from lead exposure. Therefore the CDC recommends that health care providers re-test patients:

  • younger than 6 years (72 months) of age at the time of the alert (May 17, 2017)
  • had a venous blood lead test result of less than 10 micrograms per deciliter using a Magellan Diagnostics’ LeadCare analyzer

The CDC also recommends that health care providers re-test pregnant or lactating women who had a venous blood lead test performed using a Magellan Diagnostics’ LeadCare system.

If re-testing indicates blood lead levels in excess of the CDC reference level or the state or local action level, the person should be referred for appropriate follow-up.

Magellan Diagnostics Lead Testing Devices

Magellan’s LeadCare Plus and the LeadCare Ultra Testing Systems detect the amount of lead in a blood sample obtained from a finger or heel prick (capillary) or from a vein (venous).

Magellan Diagnostics’ LeadCare Testing Systems may give inaccurate results, underestimating blood lead levels. In August 2014, Magellan Diagnostics recognized possible problems with the performance of the LeadCare Ultra and notified customers by letter on November 24, 2014. The letter instructed facilities to implement a 24-hour incubation step with the blood sample to mitigate and fully resolve what they noted was a low risk of underestimation of BLL.

On November 4, 2016, Magellan notified customers of similar problems when processing venous blood samples with the LeadCare II testing systems. Magellan recommended a four-hour incubation period for blood collection tubes laboratories received from other facilities. On November 11, 2016, Magellan notified customers that the rubber caps of the Becton Dickinson’s (BD) K2-EDTAVacutainer blood collection tubes might introduce a substance into the blood sample when used with their LeadCare II systems. Magellan recommended a minimum four-hour incubation step with the blood sample to mitigate rubber cap exposure. Most recently, on April 28, 2017, Magellan notified customers that they should no longer use BD blood collection tubes with lavender- or tan-colored tops with their LeadCare Ultra and Plus systems, and should discontinue the 24-hour incubation step.

Like the CDC, the FDA also recommends that urges parents and at-risk adults speak with a health care provider about possible re-testing. The FDA said that at this time it has no evidence that Magellan’s LeadCare systems have the same problem when processing capillary blood samples. If laboratories or health care professionals are concerned about using the LeadCare Test Systems, the alternative options are mass spectrometry or atomic absorption methods, the FDA says.

The FDA, working with the CDC, is conducting studies to identify the cause extent of the problem. The FDA recommends laboratories and health care professionals discontinue use of Magellan’s’ LeadCare System Testing Systems with venous blood samples. At this time, LeadCare systems can safely be used with capillary blood samples.

Legal Help for Inaccurate Lead Test Results

If you, your child, or someone you know has received inaccurate blood lead level test results from a Magellan LeadCare system testing device, the attorneys at Parker Waichman LLP can advise you of your options. To contact the firm, fill out the contact form or call 1-800-YOURLAWYER (1-800-968-7529).


This entry was posted in Defective Medical Devices, Flint Michigan, Health Concerns, Toxic Substances. Bookmark the permalink.

© 2005-2020 Parker Waichman LLP ®. All Rights Reserved.