A company that makes tests for lead poisoning has agreed to resolve criminal charges that it concealed for years a malfunction that resulted in inaccurately low results.
It’s the latest in a long-running saga involving Massachusetts-based Magellan Diagnostics, which will pay $42 million in penalties, according to the Department of Justice.
While many of the fault-prone devices were used from 2013 to 2017, some were being recalled as late as 2021. The Justice Department said the malfunction produced inaccurate results for “potentially tens of thousands” of children and other patients.
Doctors don’t consider any level of lead in the blood to be safe, especially for children. Several U.S. cities, including Washington, D.C., and Flint, Michigan, have struggled with widespread lead contamination of their water supplies in the last two decades, making accurate tests critical for public health.
It’s possible faulty Magellan kits were used to test children for lead exposure into the early 2020s, based on the recall in 2021. Here’s what parents should know.
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What tests were affected?
The inaccurate results came from three Magellan devices: LeadCare Ultra, LeadCare II, and LeadCare Plus. One, the LeadCare II, uses finger-stick samples primarily and accounted for more than half of all blood lead tests conducted in the U.S. from 2013 to 2017, according to the Justice Department. It was often used in physician offices to check children’s lead levels.
The other two could also be used with blood drawn from a vein and may have been more common in labs than doctor’s offices. The company “first learned that a malfunction in its LeadCare Ultra device could cause inaccurate lead test results – specifically, lead test results that were falsely low …
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A company that makes tests for lead poisoning has agreed to resolve criminal charges that it concealed for years a malfunction that resulted in inaccurately low results.
It’s the latest in a long-running saga involving Massachusetts-based Magellan Diagnostics, which will pay $42 million in penalties, according to the Department of Justice.
While many of the fault-prone devices were used from 2013 to 2017, some were being recalled as late as 2021. The Justice Department said the malfunction produced inaccurate results for “potentially tens of thousands” of children and other patients.
Doctors don’t consider any level of lead in the blood to be safe, especially for children. Several U.S. cities, including Washington, D.C., and Flint, Michigan, have struggled with widespread lead contamination of their water supplies in the last two decades, making accurate tests critical for public health.
It’s possible faulty Magellan kits were used to test children for lead exposure into the early 2020s, based on the recall in 2021. Here’s what parents should know.
Email Sign-Up
Subscribe to KFF Health News’ free Morning Briefing.
What tests were affected?
The inaccurate results came from three Magellan devices: LeadCare Ultra, LeadCare II, and LeadCare Plus. One, the LeadCare II, uses finger-stick samples primarily and accounted for more than half of all blood lead tests conducted in the U.S. from 2013 to 2017, according to the Justice Department. It was often used in physician offices to check children’s lead levels.
The other two could also be used with blood drawn from a vein and may have been more common in labs than doctor’s offices. The company “first learned that a malfunction in its LeadCare Ultra device could cause inaccurate lead test results – specifically, lead test results that were falsely low …nnDiscussion:nn” ai_name=”RocketNews AI: ” start_sentence=”Can I tell you more about this article?” text_input_placeholder=”Type ‘Yes'”]