Magellan Diagnostics, Inc.

Activity by year

Devices registered here (1)

• Lead, Atomic Absorption
  Product code DOF (opens in a new tab) · Class II · Clinical Toxicology · 21 CFR 862.3550

Recalls & enforcement

• Class IIOngoing2026-03-13
  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.
• Class IIOngoing2024-02-23
  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.
• Class IIOngoing2023-09-19
  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 tha…
• Class ITerminated2021-05-07
  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.
• Class IITerminated2018-08-08
  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.
• Class IITerminated2018-01-09
  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.
• Class ITerminated2017-05-23
  Underestimates the lead concentration of venous blood samples when the sample is analyzed with the LeadCare systems
• Class IITerminated2016-01-20
  LeadCare II Test Kits controls out of range
• Class ITerminated2014-11-29
  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 c…

FDA inspections (4)

• OAI2025-08-26
  Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
• VAI2021-06-22
  Voluntary Action Indicated · Compliance: Devices · citations posted
• VAI2019-10-21
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
• OAI2017-06-29
  Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (2)

• Warning Letter2025-12-23
  Warning Letter (opens in a new tab) · North Billerica Massachusetts
• Warning Letter2017-10-23
  Warning Letter (opens in a new tab) · North Billerica Massachusetts

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

• All facilities operated by MAGELLAN Diagnostics INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)