Magellan provides two controls in the test kits which are designed to mimic blood and are spiked with lead to specific target values with an associated acceptable range. Results of the control tests within the acceptable range indicate that the system is operating properly before testing patient samples. In
Scope of Recall
Magellan received reports that control tests of either the "Low-Control" (e.g., the "Level 1" control at approximately 9 mg/dL ± 3 mg/dL) and/or the "High-Control" (e.g., the "Level 2" control at approximately 28 mg/dL ± 4 mg/dL) generated a "low" result (i.e., "Control Out of Range-Low" ["COOR-L"]). Magellan initiated the recall because the impacted LeadCare Test Kits lots could potentially underestimate blood lead levels when processing patient blood samples.
As part of the recall to the user level, Magellan is notifying customers and distributors affected by the recall. Magellan's customer recall notification provides instructions for the return and replacement of the impacted LeadCare Test Kits (see list of affected lot numbers below).
LeadCare® II Blood Lead Test Kit
LeadCare Plus® Blood Lead Test Kit
* Lots previously included in the recall initiated on
** Lots previously included in the recall initiated on
*** Only the following sub-lots of lot 2012M are included in the recall: -08, -09, -10, -11, -12, -13, and -14
Magellan recommends the following:
Product distribution has been paused until further notice and replacement product is currently unavailable. Magellan continues to investigate the root cause of the COOR-LO failure mode and is working diligently to find a solution to resume shipments/replacements as quickly as possible. If you have questions about this recall, please contact Magellan's LeadCare® Product Support Team at 1-800-275-0102, or email at LeadCareSupport@magellandx.com.
FDA MedWatch Reporting
Adverse reactions/events or product concerns may also be reported to
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.
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