Brand
Magellan Diagnostics, Inc. Recalls
11 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Magellan Diagnostics, Inc..
11Total Recalls
7Critical
389,782Units Affected
Mar 13, 2026Most Recent
All Recalls
Every Magellan Diagnostics, Inc. Recall
Sorted by most recent. Click any recall for full details.
11 recalls
High RiskFDA
Magellan Diagnostics, Inc.
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following materials: " Senso...
Diagnostic Devices136 affectedMar 13, 2026
High RiskFDA
Magellan Diagnostics, Inc.
(1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit ; Catalog Number...
Diagnostic Devices197,893 affectedMar 13, 2026
High RiskFDA
Magellan Diagnostics, Inc.
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Senso...
Diagnostic Devices284 affectedMar 13, 2026
High RiskFDA
Magellan Diagnostics, Inc.
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary w...
Diagnostic Devices11,442 affectedSep 19, 2023
CriticalFDA
Magellan Diagnostics, Inc.
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Diagnostic Devices441 affectedMay 7, 2021
CriticalFDA
Magellan Diagnostics, Inc.
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Diagnostic Devices320 affectedMay 7, 2021
CriticalFDA
Magellan Diagnostics, Inc.
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.
Medical Devices6,143 affectedJan 9, 2018
CriticalFDA
Magellan Diagnostics, Inc.
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
Medical Devices79 affectedJan 9, 2018
CriticalFDA
Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic ...
Diagnostic Devices171,979 affectedMay 23, 2017
CriticalFDA
Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Diagnostic Devices1,016 affectedNov 29, 2014
CriticalFDA
Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Diagnostic Devices49 affectedNov 29, 2014