FDA recalls inaccurate LeadCare blood lead level tests

ANCHORAGE, Alaska (KTUU) - The U.S. Food and Drug Administration issued a first-class recall notice for some blood lead level products from Megellan Diagnostics, Inc.

The handful of products that were designed to test lead levels in one’s blood are said to be making falsely underestimated results, which may cause serious injuries to people who rely on those devices, according to a health alert issued by the Centers for Disease Control and Prevention.

“The FDA has identified this as a Class I recall, the most serious type of recall,” officials said in the alert.

The Magellan products being recalled are LeadCare® Blood Lead Tests, including certain LeadCare II, LeadCare Plus and LeadCare Ultra test kit lots. The specific lots highlighted in the recall notice were distributed between Oct. 27, 2020, and June 15 of this year.

“The FDA has concerns that the falsely low results may contribute to health risks in special populations such as young children and pregnant individuals,” the alert said. “A pregnant or lactating individual’s exposure to lead is concerning because it may cause health problems for the parent and the developing baby.”

Falsely low blood lead level results could lead to false medical assessments, which may result in patient harm, including “delayed puberty, reduced postnatal growth, decreased IQ, and inattention and behavior problems in children.”

On June 24, the FDA notified the CDC that some Magellan products were undergoing a voluntary recall. However, the FDA now recommends Magellan customers stop all use of the recalled products.

In the alert, the CDC recommends people stop using the affected test kits and retest children whose blood lead level results were less than 5 deciliters. Retesting should be done with a “venous blood sample” analyzed with “higher complexity testing,” according to the CDC.

If any Alaskans have questions on prior testing using these products and recommended actions, contact the Alaska Section of Epidemiology’s Environmental Public Health Program by phone (907-269-8000) or email (eph@alaska.gov).