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FDA Expands Recall of Magellan Dx's Lead Poisoning Systems

NEW YORK (360Dx) – The US Food and Drug Administration on Tuesday expanded a recall of lead poisoning test to include two additional testing systems from Magellan Diagnostics.

The updated Class I recall now includes Magellan's LeadCare and LeadCare II Blood Lead Testing Systems, all serial and lot numbers. In late May, the agency issued a recall for only the LeadCare Plus and LeadCare Ultra Testing Systems due to possible underestimation of blood lead levels on the systems.

In a statement today, Meridian Bioscience, the parent company of Magellan, noted that both the May and the current notices refer to problems resulting from venous blood samples, and the FDA has indicated that all of the affected systems can continue to be used with capillary blood testing.

Prior to the recall, the FDA and the US Centers for Disease Control and Prevention recommended retesting for people who had been tested for lead levels using Magellan's products. Data suggested that results from tests performed on venous blood samples were inaccurate and could be lower than the actual levels.