Magellan Diagnostics Lead Tests Recalled Due to Inaccurate Results
The U.S. Food and Drug Administration (FDA) has placed its most-serious Class I label on Magellan Diagnostics’ recall of LeadCare testing systems. The products are being recalled because they may give inaccurately low results. Failure to identify high levels of lead can lead to serious health problems, especially in children.
The product defect attorneys at Parker Waichman LLP have decades of experience representing clients in lawsuits over allegedly defective or dangerous products. The firm continues to offer free legal consultations to individuals with questions about filing a Magellan lead testing lawsuit.
Class I recalls indicate that exposure to a recalled device presents a reasonable risk of serious injury or death. According to a recall alert posted on the FDA website, Magellan Diagnostics initially only recalled the LeadCare Plus and Ultra Testing Systems because they can give inaccurately low test results. The recall was expanded to include two more lead testing systems, the LeadCare and LeadCare II Blood Lead Testing Systems. All serial numbers and kit lot numbers are affected. The recalled tests were manufactured from September 2013 to present and distributed between January 2014 and May 22, 2017.
More than 7 million LeadCare and LeadCare II blood lead testing systems are being recalled in the U.S.
The recall was issued because the test can underestimate the level of lead in the blood when using venous blood samples. “Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning,” the recall alert states. “The use of affected product may cause serious adverse health consequences.”
The LeadCare and LeadCare II testing systems are designed to measure levels of lead in blood obtained from a capillary or vein. A finger or heel prick are examples of blood from a capillary.
On May 17, 2017, the FDA issued a Safety Communication warning against using Magellan Diagnostics LeadCare testing systems with blood from a vein.
FDA, CDC Warn about Faulty Magellan Lead Tests
Both the FDA and the Centers for Disease Control and Prevention (CDC) are warning about the recalled blood testing systems. Venous blood samples used with the affected Magellan products can produce inaccurately low results.
In some patients, retesting may be appropriate, regulators state. The FDA said pregnant women, nursing mothers, and parents of children younger than six years old should speak to their doctor about whether they should get re-tested.
“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,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, according to the release. “The agency is aggressively investigating this complicated issue to determine the cause of the inaccurate results and working with the CDC and other public health partners to address the problem as quickly as possible.”
The FDA says the faulty blood test issue may date back to 2014. All four Magellan Diagnostics’ lead testing systems are affected by the warning, including LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra.
Blood taken from a capillary, such as a finger or heel stick, is believed to produce accurate results.
“We understand that parents of children and others affected by this problem will be concerned about what this means for their health,” said Patrick Breysse, Ph.D., director of the CDC’s National Center for Environmental Health, according to the release. “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. For this reason, because every child’s health is important, the CDC recommends that those at greatest risk be retested.”
There is no safe amount of lead exposure for children. As such, every state has requirements regarding lead testing in children.
Lead exposure can affect nearly every system in the body. Individuals exposed to lead may not exhibit any obvious symptoms, and oftentimes lead poisoning goes undiagnosed.
Young children who are exposed to lead can suffer damage to the central and peripheral nervous system, including learning disabilities, shorter stature, hearing problems and abnormal formation and function of blood cells. In adults, lead exposure can cause cardiovascular issues such as high blood pressure, kidney problems and reproductive problems.
Filing a Product Liability Lawsuit
Parker Waichman has spent years representing clients in lawsuits over allegedly defective or dangerous products. If you or someone you know is interested in filing a product liability lawsuit, speak with one of our attorneys today. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).