Defect Resolved, Manufacturing Resumes for LeadCare II Testing Kits

March 4, 2022

If you provide blood lead testing for children and/or pregnant people, you are likely aware that LeadCare II testing kits had been recalled. Magellan Diagnostics voluntarily recalled the test kits and suspended shipping because of a problem that had the potential to underestimate blood lead levels when processing patient samples.

The Illinois Department of Public Health (IDPH) recently sent out a notice that the product defect has been remedied and Magellan Diagnostics has resumed manufacturing and distribution of its LeadCare II test kits.

Illinois law requires that all children six years of age and younger and pregnant people receive a blood lead test upon evaluation from a healthcare professional using the Childhood Lead Risk Questionnaire or the Prenatal Lead Risk Questionnaire.

The law also requires that results of the test be reported to the IDPH and that the lead portion of the Certificate of Child Health Examination be completed.

There are penalties for healthcare professionals who do not comply with Illinois law.

If you have questions, please contact the ISMS Health Policy Research and Advocacy team by email.