Magellan Diagnostics, Inc.
8 recalls on record · Latest: Nov 15, 2023
FDA Devices Moderate Nov 15, 2023
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
FDA Devices Critical Jul 7, 2021
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
FDA Devices Critical Jul 7, 2021
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
FDA Devices Moderate Apr 11, 2018
LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
FDA Devices Moderate Apr 11, 2018
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
FDA Devices Critical Jun 14, 2017
Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. Th…
FDA Devices Critical May 24, 2017
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
FDA Devices Critical May 24, 2017