News  FDA CDC Alert - Magellan Diagnostics Recalls Several LeadCare Blood Lead Tests Due to Risk of Falsely Low Results

July 7, 2021: The U.S. Food and Drug Administration (FDA) issued a notice that Magellan Diagnostics customers that use certain LeadCare Testing Systems to screen for lead levels in blood should immediately discontinue the use of all affected test kit lots identified as part of the recall and quarantine remaining inventory.  The use of the recalled test kits might underestimate blood lead levels, resulting in unidentified lead poisoning. CDC recommends rescreening children who were tested with test kits from the affected lots.

For parents of young children

This alert is important if you have a child age younger than 6 years who was tested for blood lead using a LeadCare test kit that was recalled.  Parents and guardians should contact their child’s health care provider to find out if this alert applies to their child.

For health care providers and laboratories

The MA Department of Public Health Childhood Lead Poisoning Prevention Program (CLPPP) urges health care providers and laboratories to notify parents and guardians of children who were tested using the recalled Lead Care test kits and arrange for a retest. CDC recommends to: 

• Retest children who were tested with the recalled LeadCare test kits whose results were less than 5 µg/dL, the current CDC-recommended blood lead reference value. Retesting should be done with a venous blood sample analyzed with higher complexity testing. Link to affected test kit lots located on the FDA website.
• Retest children who were previously tested with a LeadCare test kit if the lot number of the initial test kit is unknown and the test was done between October 27, 2020, and July 6, 2021, (CDC health advisory https://emergency.cdc.gov/han/2021/pdf/CDC-HAN-00445.pdf).
• As a reminder, CDC guidance and MA CLPPP regulations require any child who had a capillary blood test result greater than or equal to 5 µg/dL to re-test with a venous re-screen.

CDC also recommends that women who are currently pregnant or breast feeding and were tested using the affected LeadCare test kit lots be retested.

Note: Medicaid will cover the cost of retesting for children enrolled in Medicaid. Families with private health insurance should contact their insurance company about coverage.

Additional resources

• Massachusetts Childhood Lead Poisoning Prevention Program or by telephone at 800-532-9571
• Massachusetts State Lead Lab
• CDC Lead Program