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Magellan Diagnostics Recalls
16 recalls on record · May 24, 2017 to April 29, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 29, 2026Medical DevicesFDA
Magellan Diagnostics, Inc. recalls LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following mat
Hazard: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
April 29, 2026Medical DevicesFDA
Magellan Diagnostics, Inc. recalls LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plus kit is provided with the following mat
Hazard: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
April 29, 2026Medical DevicesFDA
Magellan Diagnostics, Inc. recalls (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit
Hazard: Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
December 3, 2025Medical DevicesFDA
Magellan Diagnostics, Inc. recalls The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood.
Hazard: Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.
November 15, 2023Medical DevicesFDA
Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of le
Hazard: During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely elevated result (e.g., a patient false positive [PATFP] result or a Controls Out of Range-High [COOR-Hi] result).
July 7, 2021Medical DevicesFDA
Magellan Diagnostics, Inc. recalls LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Hazard: Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
July 7, 2021Medical DevicesFDA
Magellan Diagnostics, Inc. recalls LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Hazard: Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
July 7, 2021Medical DevicesFDA
Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit Catalog Number 70-6762
Hazard: Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
November 7, 2018Medical DevicesFDA
Magellan Diagnostics, Inc. recalls Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Numb
Hazard: Defect with the calibration button for lot 1808M. Level 1 and Level 2 Quality Control (QC) values will generate results of HIGH (>65 ¿g/dL). Results for patient testing with this lot will be displayed as HIGH.
April 11, 2018Medical DevicesFDA
Magellan Diagnostics, Inc. recalls LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole
Hazard: The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
April 11, 2018Medical DevicesFDA
Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (exte
Hazard: The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn their fingers if the batteries are removed while hot.
August 23, 2017Medical DevicesFDA
Magellan Diagnostics, Inc. recalls LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection
Hazard: LeadCare II Test Kits controls out of range
June 14, 2017Medical DevicesFDA
Magellan Diagnostics, Inc. recalls Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is
Hazard: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
June 14, 2017Medical DevicesFDA
Magellan Diagnostics, Inc. recalls Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in
Hazard: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
May 24, 2017Medical DevicesFDA
Magellan Diagnostics, Inc. recalls Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Hazard: LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.
May 24, 2017Medical DevicesFDA
Magellan Diagnostics, Inc. recalls Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Hazard: LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.