NEW YORK (360Dx) – The US Food and Drug Administration today issued a warning letter to Magellan Diagnostics that alleges several violations of federal law, including marketing "significantly modified versions" of two blood-based lead testing systems without the FDA's required clearance or approval.
The FDA warning also said that Magellan, an independent business unit of Meridian Bioscience, failed to submit medical device reports to the agency after becoming aware of customer complaints involving discrepancies in the test results. The agency first said in July that Magellan may have broken federal laws with the way it conducted it blood-lead poison testing. That followed an advisory from FDA in May to people who got tested for lead poisoning with technology from Magellan to get retested due to inaccurate results.
The FDA noted that it launched an investigation — including an inspection, from May 10 to June 29, of Magellan's facility — to determine the cause of the inaccurate results.
Donald St. Pierre, the FDA's acting director of the Office of In Vitro Diagnostics and Radiological Health, said in a statement, "The evidence uncovered during the inspection shows that the company put patients at risk after it recognized that its tests could provide inaccurate results, and failed to take appropriate steps to report this issue and work through a strategy to effectively mitigate problems with the FDA."
The agency added it is working with Magellan to determine the "root cause" of the problems with the blood-lead tests.
The FDA said that during the inspection, it observed "numerous violations," including failing to submit medical device reports to the FDA regarding discrepancies in test results. The inspection showed that Magellan altered two of its blood lead testing systems after they were already FDA cleared, the agency said, adding that the firm changed the amount of time that a mixture of blood samples with reagents must sit before analysis in an effort to reduce the risk of falsely low results. Magellan did not report "these significant changes to the agency for review and evaluation, as required," the FDA said.
In May, the FDA's warning covered two of Magellan's lead testing systems — LeadCare Plus and LeadCare Ultra. In June the agency expanded the recall to a Class I recall that further included Magellan's LeadCare and LeadCare II Blood Lead Testing Systems, and all serial and lot numbers.
The recalls pertained only to tests conducted with venous blood samples.
The FDA today noted that Magellan has until Nov. 10 to notify it about specific steps the firm has taken to address the violations and to prevent them from recurring. The FDA added that if Magellan fails to promptly correct the violations, it could take additional action, such as seizure, injunction, and civil money penalties.
In a statement, Meridian Bioscience said that since the FDA issued its observations at the end of its inspection, "Magellan has initiated prompt and comprehensive quality system remediation activities. Magellan will promptly submit a response to the warning letter for the agency's consideration."
Meridian Bioscience add that it and Magellan take the matter "very seriously" and are addressing the FDA's observations and the warning letter "with the highest sense of urgency."