Magellan Diagnostics is expanding its recall of the LeadCare Plus and Ultra Testing Systems to include two additional lead-testing systems, the LeadCare and LeadCare II Blood Lead Testing Systems. The recall was expanded to include these additional devices because they may underestimate the blood lead levels (BLL) and give inaccurate results when processing venous blood samples. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning, and thus may lead to serious adverse health consequences for patients.
The recall was initiated following a safety announcement in May by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). The FDA is unable to identify the root cause of the inaccurate results based on data provided by Magellan. However, the agency said it is conducting studies with the CDC to identify the cause and better characterize the extent of the problem.
Health care providers have been advised not to use venous blood samples with any LeadCare Blood Lead Testing System. However, the systems can be used with capillary blood samples. The FDA recommends that parents of children younger than 6 years of age, currently pregnant women, and nursing mothers who have been tested for lead exposure should consult with a health care professional about whether they should be retested.
Any adverse events or quality problems related to this recall should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.