Magellan Diagnostics, Inc.
North Billerica, MA
This page shows every FDA and USDA recall linked to Magellan Diagnostics, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
13
Total Recalls
2014
First Recall
2025
Most Recent
The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole...
Nov 21, 2025
· Device
Active
LeadCare Plus Blood Lead Test Kit
Catalog Number 82-0004
Jul 1, 2021
· Device
Terminated
LeadCare II Blood Lead Test Kit
Catalog Number 70-6762
Jul 1, 2021
· Device
Terminated
LeadCare Ultra Blood Lead Test Kit
Catalog Number 70-8098
Jul 1, 2021
· Device
Terminated
Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood.
Cata...
Aug 8, 2018
· Device
Terminated
LeadCare II Blood Lead Analyzer
Part Numbers: 70-6760, 70-6529-R, 70-6760-P,
70-6760-R.
Intended for in vitro...
Jan 9, 2018
· Device
Terminated
LeadCare Plus Blood Lead Analyzer
Part Number: 82-0001
Intended for the quantitative measurement of lead in a...
Jan 9, 2018
· Device
Terminated
LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls
Product Usage:
IVD test kit for the det...
Aug 15, 2017
· Device
Terminated
Magellan Diagnostics LeadCare and LeadCare II test Kits.
Product Usage:
The LeadCare Blood Lead Test Kit is...
Jun 5, 2017
· Device
Terminated
Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits.
Product Usage:
The LeadCare Blood Lead Test...
Jun 5, 2017
· Device
Terminated
Magellan Diagnostics LeadCare Ultra Blood Analyzer
Part Number: 80-0010
May 18, 2017
· Device
Terminated
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits
Part Number: 80-0010
May 18, 2017
· Device
Terminated