Posted Oct. 27, 2021. Past health advisories and alerts are archived for historical purposes and are not maintained or updated.
Magellan Diagnostics, Inc. and the U.S. Food and Drug Administration (FDA) have issued notifications about the expansion of Magellan Diagnostics’ recall of LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests, which were distributed from October 27, 2020, to August 19, 2021. Additional LeadCare II product lots, including lots previously reported to be unaffected, were recalled due to a significant risk of falsely low results. (See SRHD’s previous advisory on this topic from July 2021.) FDA has concerns that the falsely low results may contribute to health risks in special populations such as young children and pregnant individuals.
The recall now includes the majority of all test kits distributed since October 27, 2020. Product distribution has been paused until further notice, and replacement product is currently unavailable. It is unknown when replacement product will be available.
Recommendations for Clinicians
- Continue to schedule and perform required blood lead tests for patients. A venous or capillary blood sample analyzed using higher complexity methods such as inductively coupled plasma mass spectrometry (ICP-MS) or graphite furnace atomic absorption spectroscopy (GFAAS) from a CLIA compliant clinical laboratory should be used if LeadCare lead test kits are unavailable.
- Discontinue using all test kit lots identified as part of the recall.
- Retest children who were tested with the recalled LeadCare lead test kits whose results were less than CDC’s blood lead reference value. Retesting should be done with a venous blood sample analyzed with higher complexity testing.
- 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 after October 27, 2020.
- Prioritize testing for:
- Children where there is clinical concern that symptoms or developmental problems may be related to lead exposure,
- Populations at higher risk of elevated blood lead levels, such as children tested due to Medicaid-required screening or due to other state or local requirements,
- Individuals who are pregnant or breastfeeding, and
- Children who are immigrants, refugees, or recently adopted from outside of the United States.
- Discuss the recall and recommendations with a parent/caregivers of children who meet retesting criteria.
- Follow recommendations for best practices when collecting a capillary blood sample for lead testing.