NEW YORK (360Dx) – Following a warning from the US Food and Drug Administration, Magellan Diagnostics is recalling its lead poisoning test and test systems due to inaccurate test results.
The recall, announced by the FDA today, affects Magellan's LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems. The FDA said that almost 1.1 million LeadCare systems nationwide are being recalled.
Earlier this month, the agency and the Centers for Disease Control and Prevention recommended retesting for people who were tested for lead levels with Magellan's products, after data suggested inaccurate results for tests performed on blood drawn from a vein. Results from tests may be lower than the actual level of lead in the blood, the FDA and CDC said at the time, adding the issue may date back as far as 2014.
The warning at the time was only for lead tests from venous blood samples, and not from samples from finger pricks or heel stick. The FDA noted today that the recall is due to inaccurate results from venous blood samples.
"The FDA is unable to identify the root cause for the inaccurate results, based on data provided by Magellan," it said in a statement. "We are conducting studies with the Center for Disease Control and Prevention to identify the cause and better characterize the extent of the problem."
Earlier this week, Magellan, an independent business unit of Meridian Bioscience, sent a "customer safety communication" letter to affected customers advising them not to use venous blood samples with any LeadCare Blood Lead Testing Systems, the FDA said.
In mid-morning trading on the Nasdaq, shares of Meridian were up a fraction of 1 percent at $13.97.