Magellan Diagnostics, Inc.

• LeadCare® Ultra Blood Lead Analyzer Kit Ref LeadCare® Ultra

  Class II FDA UDI Active

• LeadCare® II 5X Test Kit Ref LeadCare® II

  Class II FDA UDI Active

• LeadCare® Plus Blood Lead Test Kit Ref LeadCare® Plus

  Class II FDA UDI Active

• LeadCare® Heparinized Capillary Tubes Ref LeadCare®

  Class II FDA UDI Active

• LeadCare® II Blood Lead Testing System 9X ClinicalTest Kit Ref LeadCare® II

  Class II FDA UDI Active

• LeadCare® II Blood Lead Test Kit Ref LeadCare® II

  Class II FDA UDI Active

• LeadCare® II Blood Lead Testing System 9X Test Kit Ref LeadCare® II

  Class II FDA UDI Active

• LeadCare® Blood Lead Test Kit Ref LeadCare®

  Class II FDA UDI Active

• LeadCare® Blood Collection Plungers Ref LeadCare®

  Class II FDA UDI Active

• LeadCare® II Replacement AC Adapter and Plug Set Ref LeadCare® II

  Class II FDA UDI Active

• LeadCare® II Blood Lead Analyzer Kit, Refurbished Ref LeadCare® II

  Class II FDA UDI Active

• LeadCare® II Blood Lead 6 Tests Kit Ref LeadCare® II

  Class II FDA UDI Active

• LeadCare® Blood Lead Control Kit Ref LeadCare®

  Class II FDA UDI Active

• LeadCare® Ultra Blood Lead Test Kit Ref LeadCare® Ultra

  Class II FDA UDI Active

• LeadCare® Plus Blood Lead Analyzer Kit Ref LeadCare® Plus

  Class II FDA UDI Active

• LeadCare® Ultra Blood Lead Testing System Ref LeadCare® Ultra

  Class II FDA UDI Active

• LeadCare® Plus Blood Lead Analyzer Kit Ref LeadCare® Plus

  Class II FDA UDI Active

• LeadCare® II Blood Lead Analyzer Kit Ref LeadCare® II

  Class II FDA UDI Active

• LeadCare® Plus Data ManagementSystem Ref LeadCare®

  Class II FDA UDI Active

• Leadcare (R) Ultra (Tm) Blood Lead Testing System Ref K123563

  Class II FDA 510(k) Active

• LeadCare Plus Blood Lead Testing System Ref K142705

  Class II FDA 510(k) Active

Showing the 10 most recent of 17 recalls.

• 2026

  • 4 Sep 2026 Z-0162-2027 Not yet classified Ongoing 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 error message and prevent the operator from running the test. Resulting in delayed results.
  • 13 Mar 2026 Z-1893-2026 Class II Ongoing 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.
  • 13 Mar 2026 Z-1894-2026 Class II Ongoing 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.
  • 13 Mar 2026 Z-1895-2026 Class II Ongoing 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.

• 2024

  • 23 Feb 2024 Z-0584-2026 Class II Ongoing 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.

• 2023

  • 19 Sep 2023 Z-0219-2024 Class II Ongoing 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).

• 2021

  • 7 May 2021 Z-1952-2021 Class I Terminated 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.
  • 7 May 2021 Z-1953-2021 Class I Terminated 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.
  • 7 May 2021 Z-1954-2021 Class I Terminated 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.

• 2018

  • 8 Aug 2018 Z-0285-2019 Class II Terminated 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.

Country

US

Address

101 Billerica Ave Bldg 4, N Billerica, MA, 01862

FDA FEI number

1218996