FDA Warns of False Positive Lead Test Results with LeadCare Systems and Certain Collection Tubes

The U.S. Food and Drug Administration (FDA) is issuing a safety alert to healthcare providers and laboratory personnel regarding reports of false positive results when using specific Micro Capillary Blood Collection tubes in conjunction with Magellan Diagnostics' LeadCare Testing Systems. The affected tubes are identified as Micro Capillary Blood Collection tubes with a specific lot number or product code. The FDA states that using these tubes with the LeadCare systems may lead to inaccurate lead level readings, potentially resulting in unnecessary treatment, follow-up testing, or patient anxiety. The agency is investigating the root cause of the issue and working with the manufacturer, Magellan Diagnostics, to address the problem. Healthcare providers are advised to review their inventory and discontinue use of the affected tubes. They should also consider retesting patients who may have received potentially inaccurate results using the implicated collection method. The FDA recommends using alternative, validated blood collection methods for lead testing until further notice. This communication is part of the FDA's MedWatch Safety Alert system.