FDA has not been able to identify the root cause of Magellan's inaccurate lead test results, and the recall has been expanded to include two additional testing systems.
FDA is conducting studies with the CDC to identify the cause of Magellan's faulty blood-based lead tests.
Magellan Diagnostics expanded its ongoing recall to include two additional testing systems, the LeadCare and the LeadCare II, because they may underestimate the blood lead levels (BLL) and give inaccurate results when processing venous blood samples.
The recall was first reported May 17, and now includes a total of four of Magellan's lead testing systems.
FDA said Tuesday it has not been able to identify the root cause for the inaccurate results, based on data provided by Magellan. The agency said it is conducting studies with the Center for Disease Control and Prevention (CDC) to identify the cause and better characterize the extent of the problem.
In the meantime, children younger than 6 years, pregnant women, and nursing mothers who have been tested for lead exposure should be retested if their test result was less than 10 micrograms per deciliter, the CDC said.
FDA said the issue may date back to 2014.
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, but adults who work around lead-based products or materials are also at risk for lead exposure.
Amanda Pedersen is Qmed's news editor. Contact her at [email protected].
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