WebSep 28, 2024 · 2024 updates and 2024 releases related to the LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Test Kit recalls 2024 Updates. FDA March 30, 2024: Magellan Diagnostics has resumed distribution of the LeadCare II product, which was previously unavailable. LeadCare Plus and LeadCare Ultra products are currently … WebApr 5, 2024 · So Winslow allegedly told a Magellan employee to stop studying the LeadCare II malfunction because the company needed to maintain “plausible deniability.” Magellan was acquired by Meridian ...
10/18/2024: Lab Alert: Magellan Diagnostics Expands Recall of LeadCare ...
WebMagellan Diagnostics, Inc. is recalling LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Test kits due to a significant risk of falsely low blood lead level results. FDA has concerns that the falsely low results may contribute to health risks in special populations such as young children and pregnant individuals. Magellan Diagnostics, Inc., is recalling its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of falsely low results. The FDA has significant concerns that the performance of the test may provide falsely low results and may lead to health risks in special populations … See more On May 28, 2024, Magellan notified distributors through phone calls and on June 7, 2024 sent customers an Urgent Medical Device Recall letter requesting product removal of specific lots. On June 23, 2024, Magellan … See more The LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests are used to find out a person's blood lead level. The test uses a finger or heel stick whole blood … See more the thesaures
Ex-Magellan exec with SWFL ties charged in faulty lead …
WebApr 10, 2024 · The devices in question, marketed under the names LeadCare Ultra, LeadCare II and LeadCare Plus, tested lead levels through blood draws or fingersticks and accounted for more than half of all ... WebAs 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). Catalog No. Product Lot Number Expiration Date 70-6762 ... WebJul 6, 2024 · Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results . 3 . DHEC contact information for reportable diseases and reporting requirements . Reporting of blood lead testing results (all results, regardless of test type, test result, or age of set binding in code behind wpf