The FDA today warned Meridian Bioscience (NSDQ:VIVO) subsidiary Magellan Diagnostics based on the Class I recall of its lead poisoning tests, accusing the company of failing to protect patients after it learned of problems with the tests.
The May recall, which was expanded in July, involves Magellan’s LeadCare, LeadCare II, Ultra and Plus products. The tests may underestimate blood lead levels and provide inaccurate results with venous blood samples.
Today’s warning letter came after the federal safety watchdog inspected Magellan’s plant in North Billerica, Mass., from May 10 to June 29. The inspections turned up numerous violations, the FDA said, including failure to submit medical device reports to the FDA regarding discrepancies in test results and alteration of two of the tests after winning FDA clearance “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.”
“Magellan did not report these significant changes to the FDA for review and evaluation, as required,” the agency said.
“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,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics & Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices & Radiological Health, said in prepared remarks.
“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.”
Magellan has until Nov. 10 to notify the FDA about specific steps it’s taken to address the violations and prevent their recurrence, the FDA said.