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Senators Want Answers From FDA, CDC About Lead-Poisoning Test Recall

NEW YORK (360Dx) – A group of 12 senators have fired off a letter to the US Food and Drug Administration and the US Centers for Disease Control and Prevention demanding questions to answers surrounding the recent recalls of lead-poisoning tests and systems from Magellan Diagnostics.

In May and June, the FDA issued recalls of Magellan's lead testing products after determining they provided inaccurate test results. According to the FDA and CDC, results from the tests could be lower than the actual level of lead in the blood. They added that the issue may date back to 2014.

In their letter dated June 29, the senators, all Democrats, took particular issue with the fact that for three years, the Magellan tests continued to be used and consumers continued to base healthcare decisions on possibly inaccurate results.

"We write to better understand the reasons for this significant delay, whether other tests may be similarly impacted, and what steps the FDA has taken to address this problem," the letter said.

Among the senators signing the letter were Elizabeth Warren, Sherrod Brown, Cory Booker, and Dianne Feinstein.

The legislators also criticized Magellan for their inaction, saying the company, an independent business unit of Meridian Bioscience, failed to notify the FDA of issues with the test until a year after it first knew about them, adding "Magellan's reporting to the FDA in 2015 and 2016 significantly downplayed the seriousness of the issue."

They further said they are troubled that Magellan still has not identified the origins of the testing inaccuracies and that it "continued to troubleshoot potential solutions to no avail," and that the FDA may never have known about the problems if Magellan had not requested to change the labeling on the product. That triggered an agency review, ultimately leading to the recalls.

In a statement today, Meridian Bio said that on Thursday, the FDA concluded an inspection of Magellan's quality system.

"Magellan's access to extensive dialogue with the FDA during its inspection provided valuable insight that, coupled with the help of Magellan's regulatory team, will assist us in our response to the observations," Magellan President and CEO Amy Winslow said.

Magellan noted that the testing under review is only for samples obtained by venous blood collection methods, which is about 10 percent of the testing performed on the firm's systems. FDA has said that testing performed on Magellan's LeadCare Blood Lead Testing Systems can still be used with capillary blood samples.