NEW YORK – Meridian Bioscience announced on Tuesday that its subsidiary Magellan Diagnostics has resumed manufacturing and distributing the firm's LeadCare II test kits after a product recall last year.
Certain lots of Magellan's LeadCare products were voluntarily recalled in May after a US Food and Drug Administration inspection of the company's manufacturing facility. The Class I recall was expanded in September.
Two controls are provided in the testing kits that are designed to mimic blood and are spiked with lead to specific target values with an associated acceptable range, and results from the controls within that range show the system is working correctly. Meridian found that control tests of both the "low-control" and "high-control" generated a "low" result, meaning the LeadCare kits could underestimate blood lead levels in patient blood samples.
In a statement, Meridian said it was originally believed that a defect with the plastic used to manufacture treatment reagent tubes was the source of the problem, but studies from Magellan have shown that the paperboard material used to package the tubes was the source of the contaminant.
Meridian added that Magellan has identified suitable replacement materials for the paperboard so shipping of the LeadCare II products can resume.