The FDA sent an Oct. 23 warning letter to Magellan Diagnostics as part of an ongoing investigation based on data showing its blood lead testing systems provided false results.
An investigation at Magellan’s manufacturing facility in North Billerica, Massachusetts was launched in May after the FDA issued a warning to the healthcare community 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’s May 10 through June 29 site inspection revealed several significant violations, including commercial distribution of two versions of its LeadCare systems with significant labeling modifications that had not received the FDA’s approval or clearance, as well as failing to submit medical device reports to the agency within 30 days after becoming aware of the inaccurate test results.
The agency “is deeply concerned by this situation and is warning laboratories and health care professionals that they should not use any Magellan Diagnostics’ lead tests,” CDRH director Jeffrey Shuren, said in the May notice, adding that the agency is “aggressively investigating this complicated issue to determine the cause of the inaccurate results.”
Magellan began notifying customers in 2014 of new incubation times for blood samples in an attempt to prevent the systems from underestimating lead values. The modifications were made after a study concluded that there is a “reproducible trend of increased [lead] signal with increased Sample/Treatment Reagent incubation time,” which in turn raised an issue with the original intended use of the systems.
Although the labeling was cleared when it called for immediate analysis of the blood treatment reagent mixture, the company failed to submit to the FDA for evaluation of safety and effectiveness the added incubation times of 4 hours for its LeadCare II System and 24 hours for its LeadCare Ultra System.
The changes “could significantly affect the safety or effectiveness of the device and requires submission of a new 510(k),” the warning letter states.
Magellan was also cited for several other GMP violations, including inadequate risk analysis and complaint handling, and leaving multiple corrective actions open for “extensive periods without activity.”
Read the warning letter here: www.fdanews.com/10-24-17-MagellanDiagnostics.pdf.