Magellan Diagnostics Resumes Distribution of LeadCare® II Test Kits
Meridian Bioscience (NASDAQ: VIVO) announced the resumption of manufacturing and distribution of its LeadCare II test kits after a temporary halt due to discrepancies identified in the kits' performance. The issue was traced to the paperboard packaging material, which potentially underestimated blood lead levels. Following extensive studies, suitable replacement materials have been identified to rectify the issue. Executive VP Tony Serafini-Lamanna emphasized the importance of LeadCare II in diagnosing childhood lead exposure.
- Resumption of LeadCare II test kit distribution, addressing a critical need for childhood lead exposure diagnosis.
- Identification of suitable replacement materials to enhance product reliability.
- Previous discrepancies in LeadCare II test kit performance that led to a recall and suspension of shipments.
CINCINNATI, Feb. 16, 2022 /PRNewswire/ -- Meridian Bioscience, Inc. (NASDAQ: VIVO), a leading global provider of diagnostic testing solutions and life science raw materials, announced today that Magellan Diagnostics resumed manufacturing and distribution of their LeadCare® II test kits.
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.
Tony Serafini-Lamanna, Executive Vice President – Diagnostics, commented, "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."
About Meridian Bioscience, Inc.
Meridian is a fully integrated life science company that develops, manufactures, markets, and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy, and simplicity that are redefining the possibilities of life from discovery to diagnosis. Through discovery and development, we provide critical life science raw materials used in immunological and molecular tests for human, animal, plant, and environmental applications. Through diagnosis, we provide diagnostic solutions in areas including gastrointestinal and upper respiratory infections and blood lead level testing. We build relationships and provide solutions to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers, and biotech companies in more than 70 countries around the world.
Meridian's shares are traded on the NASDAQ Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
Contact:
Charlie Wood
Vice President – Investor Relations
Meridian Bioscience, Inc.
Phone: +1 513.271.3700
Email: mbi@meridianbioscience.com
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SOURCE Meridian Bioscience, Inc.
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