What Are Magellan LeadCare Testing Devices?
Magellan LeadCare devices are machines used to detect levels of lead in a person’s blood, most commonly in children. They were purchased by doctors, hospitals, laboratories, and healthcare groups to be used to perform blood lead level testing in clinics, hospitals, and laboratories.
Between 2006 and 2016, many LeadCare devices may have given falsely low levels of lead concentrations. This may have delayed or prevented children and others from timely medical treatment.
What Is Lead Testing?
Lead testing is commonly performed on children and others who may have been exposed to lead-based products in their home, work, or school environments. It is performed using a small amount of blood collected from the veins by a phlebotomist.
Who Needs Lead Testing?
The U.S. Centers for Disease Control and Prevention have stated that no concentration level of lead in the blood is safe. Toxicities that occur as a result of lead poisoning may be irreversible and will worsen with further exposure.
In some areas, lead testing is performed on many or most children. In other areas, lead testing is performed only when a child or adult is suspected to have been exposed to high levels of lead.
What Causes Lead Toxicity?
Lead poisoning often occurs in children and adults when lead-contaminated food or other contaminated items are ingested, when lead-contaminated water is consumed, or when lead-contaminated dust is inhaled.
Common causes of lead exposure include lead paints in homes and on toys which may chip off to be consumed by small children, lead-contaminated dust from home reconstructions, and most concerningly – lead-contaminated water from old or degrading lead pipes in public water systems.
Who Is at Risk From Lead Toxicity?
Children are particularly vulnerable as lead may affect a developing brain and neurological systems more severely. Pregnant women may also be more affected by lead poisoning which results in developmental disorders, low birth weight, and premature birth of the infant.
Lead exposure can often result in slowed neurologic development, learning disability, behavioral, and other developmental disorders. High levels of lead may harm the brain and central nervous system, resulting in coma, convulsions, or even death.
What Magellan Devices Were Defective?
Magellan Diagnostics devices that may have been defective include:
- LeadCare Ultra
- LeadCare II
- LeadCare Plus
How Were the LeadCare Devices Defective?
Magellan LeadCare testing devices may have produced inaccurate results from thousands of lead tests. Testing results may have shown results that were much lower than actual concentration levels. Because lead levels were underreported, patients may not have been treated for lead exposure in a timely and appropriate manner.
It may have prevented further investigation or avoidance of the origins of any lead exposure such as continued consumption of contaminated drinking water. It may also have placed financial and ethical burdens on clinics, hospitals, laboratories, and medical groups who paid for a machine that did not work and put their patients in danger.
Were LeadCare Devices Recalled?
Magellan LeadCare testing devices were introduced in 2006 and used in thousands of hospitals, clinics, and laboratories. Company officials reportedly became aware of inaccuracies in testing in 2013 but did not disclose the defects due to a pending sale of the company. Once the defects were discovered within Magellan, company employees were ordered to stop studying the defects so that they would remain hidden.
After Magellan was acquired in a completed sale, the defects were disclosed to the FDA. The Agency then issued a recall for affected devices in 2017. This delay may have placed tens of thousands of children and other patients at continuing risk.
Have Magellan LeadCare Patients Been Informed of Risk?
Many parents and other patients may not know of past testing inaccuracies or may not have been told of what method or devices were used in testing. Because many parents and others may be unaware of the LeadCare testing concerns, the Federal Bureau of Investigation (FBI) has launched an investigation intending to identify potential victims of this criminal fraud.
Are There Any Magellan LeadCare Lawsuits for Children or Adults?
False or inaccurate lead testing results may have left parents, families, and others unaware of the dangers of lead poisoning and prevented actions to stop further exposure. It may have delayed or prevented treatment which would have been obtained if accurate testing results had been given.
Parents and caregivers of children or others who were tested for levels of lead in the blood between 2006 and 2017, may have been placed at risk of serious health effects if the device used for testing was made by Magellan and may be eligible for compensation.
Is Magellan Facing Other Lawsuits?
Magellan LeadCare testing devices were purchased and used in Hospitals, Laboratories, Medical Clinics, and Physicians’ Offices. Businesses and organizations who purchased the devices were expecting that the machines would provide accurate results to patients. Underreporting blood concentrations may have led to failures for both the patient and the businesses who used the machines. Medical businesses and organizations may have suffered
Magellan LeadCare testing devices were purchased or used in doctors’ offices, medical clinics, hospitals, and testing laboratories all over the U.S. Businesses and organizations who purchased the machines may have been placed at risk of financial loss, harm, or other damages and may be eligible for compensation.