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News CDC Alert - Magellan Diagnostics Issues Expanded Recall for LeadCare II Blood Lead Tests Due to Risk of Falsely Low Results

8/30/2021
  • Childhood Lead Poisoning Prevention Program
  • Bureau of Environmental Health
  • On August 30, 2021, Magellan Diagnostics, the manufacturer of LeadCare test kits used for screening for blood lead levels issued a temporary ‘cease and desist’ for all point of care (POC) testing using LeadCare II analyzers.
  • Magellan recommends that providers discontinue use of all test kits and quarantine remaining inventory.
  • This recall is a significant expansion from the July 7th recall of LeadCare test kits. Similar to the initial recall, these test kits may incorrectly report falsely low blood lead levels.
  • This recall affects approximately 30% of all annual lead testing for children in Massachusetts, which constitutes more than 58,000 capillary tests that are analyzed with LeadCare II devices.
  • Early identification of lead exposed children is crucial for their long-term health and well-being. There is no safe level of lead in blood and childhood exposure to relatively low levels can cause severe and irreversible health effects. Preliminary 2020 data indicates lower screening levels for lead because of the pandemic. The recall of LeadCare II analyzers may further reduce screening or re-screening if alternative testing options are not easily accessible.
  • DPH’s Childhood Lead Poisoning Prevention Program (CLPPP) will be contacting the affected pediatric and family medical care providers to recommend that they immediately discontinue use of these faulty test kits.
  • CLPPP will recommend that providers use other approved capillary test kits and contract with private laboratories or the State Public Health Lab for analyses of lead testing.
  • DPH is awaiting updated information from FDA, and CDC guidance regarding the need for retesting of children who were screened using these faulty test kits. In the interim, CDC referred to prior re-testing guidance.

Childhood Lead Poisoning Prevention Program 

We help prevent, screen, diagnose, and treat childhood lead poisoning. We work to eliminate sources of poisoning through research and educational, epidemiological, and clinical and environmental activities.

Bureau of Environmental Health 

We work to protect the public from a variety of environmental exposures. These exposures can occur when we come into contact with pollutants in the air, water, or soil – whether they result from human activities or the natural environment, like radon in soil.
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