10/18/2021: Lab Alert: Magellan Diagnostics Expands Recall of LeadCare Blood Lead Tests Due to Risk of Falsely Low Results

CDC's Laboratory Outreach Communication System (LOCS)

This LOCS message is an update to Lab Alert: Magellan Diagnostics Recalls Several LeadCare Blood Lead Tests Due to Risk of Falsely Low Results that CDC issued on July 6, 2021.

Audience: Clinical Laboratory Professionals

Level: Laboratory Alert

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.

The use of these devices may cause serious injuries because they might underestimate blood lead levels. FDA has identified this as a Class I recall, the most serious type of recall.

CDC has also distributed an announcement about this recall via the Health Alert Network (HAN).

This LOCS message is an update to Lab Alert: Magellan Diagnostics Recalls Several LeadCare Blood Lead Tests Due to Risk of Falsely Low Results that CDC issued on July 6, 2021.

Recommendations for Laboratories and Health Care Providers:

  • Promptly complete and return the Customer Notification Form to LeadCareSupport@magellandx.com or FAX to (978) 600-1480 (this will indicate receipt of this field correction notice).
    • Complete this form even if you have no remaining inventory.
    • Once the form has been submitted, Magellan Technical Support will process the form and  provide a Return Material Authorization (RMA) to return any remaining inventory to Magellan Diagnostics, Inc. and receive replacement product.
    • Product will be replaced based on availability; replacement product is NOT currently available.
  • 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 blood lead levels above CDC’s blood lead reference value, 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 retesting recommendations with a parent or caregiver of children who meet the retesting criteria.
  • Follow recommendations for best practices when collecting a capillary blood sample for lead testing.

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Thank you,

The Laboratory Outreach Communication System

Laboratory Outreach Communication System (LOCS) | Division of Laboratory Systems (DLS)

Center for Surveillance, Epidemiology, and Laboratory Services (CSELS)

Centers for Disease Control and Prevention (CDC)