Magellan Diagnostics Distributed Unapproved Testing Systems, FDA Says

The FDA sent a warning letter to Magellan Diagnostics as part of an ongoing investigation based on available data that show its blood lead testing systems have provided false results.

An investigation at Magellan’s manufacturing facility in North Billerica, Massachusetts was launched in May after the FDA warned Americans not to use any of the firm’s blood lead testing systems — LeadCare; LeadCare II; LeadCare Plus; and LeadCare Ultra — as they have provided results that are lower than the actual level of lead in the blood samples.

Magellan, a subsidiary of Meridian Bioscience, received a Form 483 after the FDA site inspection revealed several “significant violations of the law,” including commercially distributing two versions of its LeadCare systems with significant labeling modifications that had not received the required FDA approvals or clearances, as well as failing to submit medical device reports to the agency within 30 days after becoming aware of the inaccurate test results.