Magellan Diagnostics has resumed manufacturing and distribution of its LeadCare II test kits — a test for childhood lead exposure— which was originally suspected of having a defect.
The Magellan quality management system identified discrepancies in the performance of LeadCare test kits. It was originally suspected that a defect with the plastic used to manufacture treatment reagent tubes was the source of this discrepancy; however, studies have shown that the paperboard material used to package Treatment Reagent tubes is the source of the contaminant.
As the issue had the potential to underestimate blood lead levels when processing patient samples, Magellan voluntarily recalled test kits and temporarily suspended shipping. Magellan has conducted numerous studies and experiments to understand the root cause of the issue and has identified suitable replacement materials such that shipments can resume.
“LeadCare II is on the frontlines of early diagnosis of childhood lead exposure. Our team is intensely focused on getting LeadCare II testing back into clinician’s offices to help quickly identify and address the effects of lead poisoning,” says Tony Serafini-Lamanna, executive vice president – Diagnostics, Meridian Bioscience Inc., the parent company of Magellan.
For more information, visit www.meridianbioscience.com.
Featured image: LeadCare II is designed to provide early diagnosis of childhood lead exposure. Photo: Meridian Bioscience.