Medical Devices

Safety Issue on Magellan Diagnostics LeadCare Testing Systems

LeadCare Lead Testing Systems Safety Issue

Magellan Diagnostics Inc. manufactures the following lead testing systems: LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra. The LeadCare Testing Systems detect the amount of lead in a blood sample obtained from finger or heel prick (capillary) or from a vein (venous). On May 17, 2017, the FDA issued a warning regarding all four Magellan Diagnostics LeadCare Testing Systems when processing venous blood samples, in the United States. There are other methods of blood lead testing available Inductively coupled plasma-mass spectrometry (ICP-MS) or graphite furnace atomic absorption spectroscopy (GFAAS), but these test methods can only be run in a large-capacity laboratory.

The FDA is warning laboratories and health care professionals that they should no longer use Magellan Diagnostics Inc.’s LeadCare System tests with venous blood samples. All four LeadCare Testing Systems marketed in the U.S. are affected by this warning: LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra. The FDA has no reason to believe that other methods of lead testing such as mass spectrometry or atomic absorption are affected by this issue.

Magellan LeadCare testing systems may underestimate blood lead levels (BLLs) and give inaccurate results when processing venous blood samples. Falsely lower test results may lead to improper patient management and treatment for lead exposure or poisoning.

At this time, the FDA has no evidence that Magellan’s LeadCare Testing Systems have the same problem when processing capillary blood samples, which is more commonly used in young children.

At this time, the FDA has no evidence that Magellan’s LeadCare Testing Systems have the same problem when processing capillary blood samples, which is more commonly used in young children.

FDA’s Ongoing Investigation of LeadCare Testing Systems

At this time, the FDA is unable to identify the root cause for the inaccurate results based on data provided by Magellan Diagnostics, but is aggressively investigating this issue with the manufacturer, health care facilities, and the Centers for Disease Control and Prevention (CDC). This includes reviewing data already provided by Magellan Diagnostics, requesting additional information from the company regarding the issue, inspecting the company’s manufacturing facility, and having additional studies performed. We will update this webpage with critical information as necessary.

FDA Activities: 

  • On May 17, 2017, the FDA issued a Safety Communication - FDA Warns Against Using Magellan Diagnostics LeadCare Testing Systems with Blood Obtained from a Vein: FDA Safety Communication - to warn laboratories and health care providers not to use Magellan Diagnostics Inc. LeadCare Systems tests with venous blood samples.
  • On June 29, 2017, the FDA completed an inspection at Magellan Diagnostics’ manufacturing facility. The detailed observations from the inspection can be found in the Form 483 issued at the conclusion of the inspection. We are carefully reviewing the evidence collected during the inspection to determine if there have been violations of federal law and whether further action is warranted.
  •   On July 6, 2017, the FDA completed an inspection at Beckton Dickinson (BD) & Company's manufacturing facility. The detailed observations from the inspection can be found in the Form 483 issued at the conclusion of the inspection. We are carefully reviewing the evidence collected during the inspection to determine if there have been violations of federal law and whether further action is warranted.
    •  The FDA issues a Form 483 at the conclusion of a facility inspection, if an investigator has observed any conditions that in the investigator’s judgment may be violations of federal law (e.g., the Federal Food, Drug and Cosmetic Act). The observations do not represent a final decision by FDA about the facility’s compliance. For more information on FDA’s Form 483 visit the FDA Form 483 Frequently Asked Questions webpage.

Information for Health Care Providers and Health Care Facilities

The FDA recommends laboratories and health care professionals review the Safety Communication and:

  • Discontinue using Magellan Diagnostics’ LeadCare System tests with venous blood samples. At this time, all LeadCare Systems can be used with capillary blood samples.
  • Report any adverse events to the FDA and to Magellan Diagnostics.
  • If laboratories or health care professionals are concerned about using the LeadCare Testing Systems, the alternative options are mass spectrometry or atomic absorption methods. These are not point-of-care tests, and may be available only from larger-capacity laboratories, such as reference labs.

Information for Patients

The FDA is encouraging parents and at-risk adults to follow CDC’s recommendations listed in its May 17 Health Advisory for any necessary re-testing based on this warning.

Page Last Updated: 08/17/2017
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