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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 Devices·136 affected·Mar 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 Devices·197,893 affected·Mar 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 Devices·284 affected·Mar 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 Devices·11,442 affected·Sep 19, 2023
CriticalFDA
Magellan Diagnostics, Inc.
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Diagnostic Devices·441 affected·May 7, 2021
CriticalFDA
Magellan Diagnostics, Inc.
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Diagnostic Devices·320 affected·May 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 Devices·6,143 affected·Jan 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 Devices·79 affected·Jan 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 Devices·171,979 affected·May 23, 2017
CriticalFDA
Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Diagnostic Devices·1,016 affected·Nov 29, 2014
CriticalFDA
Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Diagnostic Devices·49 affected·Nov 29, 2014