A lead poisoning test manufacturer has settled criminal charges after admitting for years to hiding a flaw that led to falsely low readings.
It’s the most recent development in a protracted legal battle involving Massachusetts-based Magellan Diagnostics, which the Department of Justice claims will pay $42 million in fines.
Even though a large number of the defective devices were in use from 2013 to 2017, some recalls weren’t issued until 2021. According to the Justice Department, “potentially tens of thousands” of children and other patients received erroneous results as a result of the problem.
No blood lead level is deemed safe by doctors, especially for young patients. Accurate testing is essential for public health since several American communities, including Flint, Michigan, and Washington, D.C., have battled widespread lead pollution of their water sources in the past 20 years.
Based on the 2021 recall, it’s likely that defective Magellan kits were used to test kids for lead exposure as late as the early 2020s. What parents should know is as follows.
Which tests were impacted?
LeadCare Ultra, LeadCare II, and LeadCare Plus are the three Magellan devices that produced the erroneous results. According to the Justice Department, one, the LeadCare II, predominantly uses finger-stick samples and was responsible for more than half of all blood lead tests performed in the United States between 2013 and 2017. It was frequently used to measure children’s lead levels in doctor’s offices.
The other two may have been more frequent in labs than in doctor’s offices, and they may also be used with vein-cleaned blood. When requesting regulatory approval to sell the product in June 2013, the business “first learned that a malfunction in its LeadCare Ultra device could cause inaccurate lead test results—specifically, lead test results that were falsely low,” according to the DOJ. However, the settlement claims that it continued to promote the tests without disclosing that knowledge.
According to agency testing conducted in 2013, the LeadCare II device was impacted by the same problem. The majority of the three types of test kits delivered after October 27, 2020 were included in a recall in 2021.
“The underlying issues that affected the results of some of Magellan’s products from 2013 to 2018 have been fully and effectively remediated,” the business stated in a press release announcing the settlement, adding that the tests it presently sells are safe.
What is the meaning of a deceptively low result?
During a child’s first pediatrician visit and again at age two, testing is frequently done on them. Children that have high amounts of lead run the risk of experiencing developmental delays, low IQs, and other issues. Furthermore, it’s possible that symptoms like irritation, poor appetite, or stomachaches won’t show up until high levels are achieved.
Falsely low test results could indicate that doctors and parents were ignorant of the issue.
That’s concerning because the initial focus of treatment for lead poisoning is mostly preventive. According to Janine Kerr, a health educator with the Virginia Department of Health’s Childhood Lead Poisoning Prevention Program, results indicating elevated levels should compel parents and health officials to identify the sources of lead and take precautionary measures to prevent continued lead intake.
There are several ways that children can come into contact with lead. These include eating some brands of cinnamon-flavored applesauce, as recently reported, or drinking water tainted with lead from old pipes, as in the cases of Flint and Washington. Lead-based paint particles are also frequently found in older homes.
Now, what should parents do?
Maida Galvez, a pediatrician and professor at the Icahn School of Medicine at Mount Sinai in New York, stated, “Parents can contact their child’s pediatrician to determine if their child had a blood lead test with a LeadCare device” and discuss whether a second blood lead test is necessary.
In 2017, the Centers for Disease Control and Prevention advised that patients be retested if they were expecting, nursing, or had children under the age of six, and if a Magellan device from a venous blood draw had revealed a blood lead level of less than 10 micrograms per deciliter. This was in response to an earlier recall of certain Magellan devices.
Children whose results were below the current CDC standard threshold of 3.5 micrograms per deciliter were advised to retest, according to the 2021 recall of Magellan devices. Finger-stick tests constituted a large portion of those tests.
According to Kerr of the Virginia Department of Health, her office has not received many calls regarding that recall.
“We did get a lot of questions about the applesauce recall,” Kerr said, adding that “the finger-stick tests are not that widely used in Virginia.”
Regardless, she stated that “speaking with a health care provider is the best course of action for parents.”
