Magellan Diagnostics recalls

Magellan Diagnostics appears in 17 official U.S. recall notices indexed by RecallRadar, most recently on 2026-10-21.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• LeadCare II Blood Lead Test Kit
  FDA Device · Class III · 2026-10-21 · Magellan Diagnostics
  Reason: In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an…
• LeadCare¿ Plus Blood Lead Test Kit
  FDA Device · Class II · 2026-04-29 · Magellan Diagnostics
  Reason: 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…
• LeadCare Ultra Blood Lead Test Kit
  FDA Device · Class II · 2026-04-29 · Magellan Diagnostics
  Reason: 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…
• (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, (4)LeadCare¿ II 9X Blood Lead Test Kit
  FDA Device · Class II · 2026-04-29 · Magellan Diagnostics
  Reason: 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…
• The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood
  FDA Device · Class II · 2025-12-03 · Magellan Diagnostics
  Reason: 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 r…
• LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only
  FDA Device · Class II · 2023-11-15 · Magellan Diagnostics
  Reason: 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. Manu…
• LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
  FDA Device · Class I · 2021-07-07 · Magellan Diagnostics
  Reason: 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.
• LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
  FDA Device · Class I · 2021-07-07 · Magellan Diagnostics
  Reason: 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.
• LeadCare II Blood Lead Test Kit Catalog Number 70-6762
  FDA Device · Class I · 2021-07-07 · Magellan Diagnostics
  Reason: 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.
• Magellan LeadCare¿ II Blood Lead Test Kit
  FDA Device · Class II · 2018-11-07 · Magellan Diagnostics
  Reason: 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.
• LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample
  FDA Device · Class II · 2018-04-11 · Magellan Diagnostics
  Reason: 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.
• 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 Device · Class II · 2018-04-11 · Magellan Diagnostics
  Reason: 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.
• LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood
  FDA Device · Class II · 2017-08-23 · Magellan Diagnostics
  Reason: LeadCare II Test Kits controls out of range
• Magellan Diagnostics LeadCare and LeadCare II test Kits
  FDA Device · Class I · 2017-06-14 · Magellan Diagnostics
  Reason: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
• Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits
  FDA Device · Class I · 2017-06-14 · Magellan Diagnostics
  Reason: Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
• Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
  FDA Device · Class I · 2017-05-24 · Magellan Diagnostics
  Reason: 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 rubbe…
• Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
  FDA Device · Class I · 2017-05-24 · Magellan Diagnostics
  Reason: 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 rubbe…