In May, the Food and Drug Administration (FDA) warned that Magellan Diagnostics LeadCare lead poisoning detection test systems performed on blood drawn from the vein may provide inaccurate results, with the goal of alerting laboratories, health care professionals and others who may have been impacted by this issue. The agency also launched an aggressive investigation to determine the cause of inaccurate results and promised to keep consumers informed on what the agency learned.
Magellan also issued a recall of its LeadCare Plus, LeadCare Ultra Testing Systems, LeadCare and LeadCare II Blood Lead Testing Systems. The issue was that the devices may underestimate the blood lead levels in test samples and give inaccurate results. 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.
This week, the FDA announced that as part of its investigation, agency officials inspected Magellan Diagnostics facility in North Billerica, Massachusetts, during which several potential violations of federal law were identified. “We are carefully reviewing the evidence collected during the investigation to determine if … further action is warranted,” the FDA said in a statement.
The agency said it is taking these observations and the risks these tests may have posed to patients very seriously and is encouraging people to follow the recommendations for testing issued by both the FDA and the Centers for Disease Control and Prevention (CDC).
“As we continue our inspection into the cause of the inaccurate results, [we] will continue to provide updates on our findings and any changes to our recommendations,” the agency said.