WebApr 12, 2024 · The Magellan Diagnostics products — marketed under the names LeadCare Ultra, LeadCare II and LeadCare Plus — tested lead levels through blood draws or fingersticks. The three products accounted for more than half of all blood lead tests conducted in the U.S. from 2013 through 2024, according to the U.S. Attorney’s Office for … WebMagellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results Information on Lead Exposure Magellan Diagnostics Form 483 (PDF - 2.5MB)
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WebMay 7, 2024 · REQUIRED ACTIONS: LeadCare blood lead test kits, Catalog Numbers: 70-6762, 82-0004, and 70-8098 - Per laboratory policies and procedures, laboratories should evaluate patient test results that were generated with the impacted lots. - Magellan is recommending retesting of suspect results below 5 mg/dL. - All blood Lead test results … WebApr 5, 2024 · LeadCare II, which was predominantly used to test fingerstick samples, accounted for more than half of all blood lead tests conducted in the United States from 2013 through 2024. LeadCare Plus and LeadCare Ultra were … shell coloring pages free printable
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WebApr 14, 2024 · Magellan Aerospace, New York (Corona, Queens) is looking for a full-time CNC Programmer proficient in CAD/CAM software (CATIA, NX, VERICUT) with … WebJul 6, 2024 · Magellan Diagnostics, Inc. is recalling its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of falsely low blood lead level results. The FDA has concerns that the falsely low results may contribute to health risks in special populations such as young children and pregnant individuals. WebFor The Magellan LeadCare UltraM Blood Lead Testing System 1.SIBMITTERI51O(K) HOLDER Magellan Diagnostics, Inc. 10 1 Billerica Aye, Building 4 North Billerica, MA 0 1862 Contact Person: Reba LegerA162oj3 Telephone: +1 (978) 248-4811 2. DEVICE NAME Proprietary Name: LeadCare® Ultra M Blood Lead Testing System CommonlUsual … shell colony chembur