Manufacturer Recall of Blood Lead Test Kits Impacts Testing for Kids, Pregnant People

February 11, 2022

Do you provide blood lead testing for children and/or pregnant people? If you do, your current process may have to include a temporary detour.

Faulty LeadCare II testing kits have been recently recalled by Magellan Diagnostics and the Centers for Disease Control and Prevention (CDC) resulting in a potential shortage of supplies for this type of testing.

The Illinois Department of Public Health (IDPH) is aware that many Illinois healthcare professionals use LeadCare II units in their offices as the primary means of performing blood lead tests.

Until the product defect is remedied by the manufacturer, healthcare professionals will need to contact a certified reference laboratory to perform analyses of samples taken in their offices.

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 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.