Company Hid Malfunctions in Lead Tests for Children, Pleads Guilty to Federal Criminal Charges
Magellan Diagnostics pled guilty to two counts of violating the Food, Drug, and Cosmetic Act (FDCA) for misbranding a medical device and then introducing it into the market in multiple states. Sentencing is scheduled for Oct. 9, 2024
Millions in Fines
Magellan is also expected to pay a fine of $28.1 million, forfeit $10.9 million in revenue from the misrepresented tests and pay a minimum of $9.3 million in compensation to patients who were impacted by the incorrect test results, per the plea agreement.
Ineffective Devices
The LeadCare Ultra and LeadCare II devices at the center of this scandal are used to detect levels of lead and lead poisoning in blood samples. Sampling is done either through fingerstick samples or by drawing blood. Between 2013 and 2017, their devices made up over half of all lead test samples administered in the United States.
In the plea agreement, Magellan admitted that they had not notified the FDA in a timely manner about a critical failure in their LeadCare devices that resulted in erroneous readings of lead levels in blood samples. Magellan had also failed to notify the FDA or wait for approval, over changes to the instructions provided to LeadCare device users.
Misleadingly Low Lead Levels
In mid-2013, while attempting to obtain FDA clearance, Magellan first discovered that the LeadCare Ultra produced results that were not only inaccurate but misleadingly low. Regardless, they ultimately released LeadCare Ultra later in 2013 without disclosing anything.
By August 2014, customers began to question the accuracy of LeadCare Ultra and filed complaints. According to FDA regulations, companies have 30 days to file a report if they discover malfunctions with their products, but Magellan failed to comply.
Magellan then addressed the malfunctions of LeadCare Ultra in a letter and advised customers to wait 24 hours before running tests, which contradicted the FDA-approved instructions. Magellan then waited until April 2015 to report to the FDA the failures of LeadCare Ultra and the changes made to user instructions, according to the press release.
In August 2015, Magellan updated the label instructions on LeadCare Ultra, requiring a 24-hour wait before testing samples instead of testing immediately, without providing the FDA advance notice of the change or reporting corrections in the device. The FDA later found that Magellan’s LeadCare devices failed to test samples accurately which resulted in a recall and warning to the public to avoid using the devices.
Acquisition by Meridian Bioscience
Ironically, this scandal did not deter the acquisition of Magellan Diagnostics by Meridian Bioscience, Inc., in 2016. In fact, a March 2016 press release from Meridian Bioscience describes Magellan as a “leading provider of point-of-care lead testing systems” and touts their “engineering, development, and manufacturing of FDA-cleared products for the testing of blood to diagnose lead poisoning in children and adults,” even though at the time of this press release Magellan had previously notified the FDA of the malfunctions in their devices a year earlier in April 2015.
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