The FDA first warned consumers in May of 2017 that Magellan’s lead tests may provide inaccurate results when used with blood drawn from the vein and held in BD’s blood collection tubes. Today, the U.S. regulatory watchdog reported that BD uncovered the chemical explanation for why its tubes were linked to false results with Magellan’s LeadCare tests.
The company found that the affected tubes’ rubber stoppers contained a chemical called thiuram. The chemical can release sulfur-containing gases that dissolve into blood and bind to lead particles, making it hard for Magellan’s lead tests to correctly detect the concentration of lead in a given sample.
The FDA said today that it continues to recommend that consumers not use Magellan’s lead tests with blood samples taken from the vein, regardless of the blood collection tube manufacturer, since thiuram may be used to make other rubber stoppers. The agency added that it is investigating the issue with other blood collection tube makers.
“Lead exposure can affect nearly every system in the body, produces no obvious symptoms, and frequently goes unrecognized, potentially leading to serious health issues. Lead poisoning is particularly dangerous to infants and young children. While recommendations for lead screening in adults differ from state to state, all states require children to be screened for lead exposure,” Donald St. Pierre, who leads the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in prepared remarks. “Some adults are also at risk for lead exposure, including those who work around products or materials that contain lead.”
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.