The FDA has announced that Magellan Diagnostics is recalling 13 lots of its LeadCare blood lead tests due to a “significant risk of falsely low results.” This is a Class I recall, which means the issue could lead to serious injury or death.
The recall includes 10 lots of the company’s LeadCare II tests and three additional lots of the LeadCare Plus and LeadCare Ultra tests. All lots were manufactured from October 2020 to May 2021 and distributed from October 2020 to June 2021.
“The FDA has significant concerns that the performance of the test may provide falsely low results and may lead to health risks in special populations such as young children and pregnant individuals,” according to the announcement. “A pregnant or lactating individual's exposure to lead is concerning because it not only may cause health problems for the parent but can result in lead exposure to the developing baby. Obtaining falsely low results may lead to patient harm including delayed puberty, reduced postnatal growth, decreased IQ, and inattention and behavior problems in children.”
The tests, designed to determine a patient’s blood lead level, are common in U.S. laboratories, doctor’s offices, clinics and hospitals. Customers have been instructed not to use any products included in this recall. Also, any test results generated by these products should be evaluated and potentially redone.
The FDA did emphasize that no replacement tests are currently available from Magellan Diagnostics.
Read the full announcement here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.