The FDA has sent a warning letter to Magellan Diagnostics, Inc., for violations of federal law, including marketing significantly modified versions of two of its blood lead testing systems without the FDA’s required clearance or approval and failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results.
In May 2017, the FDA told Americans that using Magellan’s LeadCare test systems on blood drawn from the vein may provide falsely low results. At that time, the agency launched an investigation to determine the cause of the inaccurate results, which included an inspection (May 10 to June 29) of Magellan’s facility.
“The FDA has serious concerns about Magellan Diagnostics’ actions after learning about inaccuracies in results using its blood lead testing devices—tests that the American people depend on,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health. “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. We take the violations described in the warning letter very seriously and are continuing to work with the company to investigate the root cause of the falsely low test results.”
During the inspection, the FDA’s investigators observed numerous violations, including failing to submit medical device reports to the FDA regarding discrepancies in test results. In addition, the inspection showed that Magellan altered two of its blood lead testing systems after they were already FDA-cleared by changing the amount of time that the mixture of blood samples with the reaction substance (reagent) must sit before analysis in an effort to reduce the risk of falsely low results; however, Magellan did not report these significant changes to the FDA for review and evaluation, as required.
Magellan Diagnostics has until November 10, 2017, to notify the FDA about specific steps the company has taken to address these violations and to prevent them from recurring. If the company fails to promptly correct these violations, the FDA may take additional action, such as seizure, injunction, and civil monetary penalties.
The FDA continues to encourage people to follow the Centers for Disease Control and Prevention (CDC) re-testing recommendations and the FDA’s recommendations for health care professionals. In addition, the FDA is continuing the investigation into the root cause of the inaccurate lead test results and working with the CDC on an independent analysis of Magellan Diagnostics’ LeadCare System tests.
Magellan’s parent company, Meridian Bioscience, Inc., said in a statement that Magellan “has initiated prompt and comprehensive quality system remediation activities.” The companies said that they are committed “to strengthening Magellan’s quality system and ensuring all aspects of the system are in full compliance,” that they “take this very seriously,” and that they are addressing the issue “with the highest sense of urgency.”