CDC LOCS Lab Alert: Magellan Diagnostics Recalls Several LeadCare Blood Lead Tests Due to Risk of Falsely Low Results

On July 1, 2021, the U.S. Food and Drug Administration (FDA) issued a notice that Magellan Diagnostics, Inc., is recalling its LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests due to a significant risk of falsely low results.

FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries.

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

Actions for Laboratories and Health Care Providers:

• Discontinue use of all test kit lots identified as part of the recall and quarantine remaining inventory.
• Laboratories should evaluate patient test results that were generated with the impacted lots.
• Confirm suspect results with an alternative lead testing option, such as those using inductively coupled plasma mass spectrometry or graphite furnace atomic absorption spectroscopy at a high complexity, CLIA-certified, reference laboratory.
• Promptly complete and return the Customer Notification Form in the Urgent Medical Device Recall letter 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.
• After the form has been submitted, contact Magellan Technical Support 1-800-275-0102 to obtain a FedEx label to return any remaining inventory to Magellan and receive replacement product.
• Be aware, product will be replaced based on availability; replacement product is NOT currently available.

LeadCare II lots 2012M, 2018M, and 2102M are not impacted by this recall. Laboratories and health care providers may continue to use these tests and should report any failed Quality Control or suspected test results to Magellan Diagnostics.

For questions, contact us at LOCS@cdc.gov.

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This Lab Alert was originally published by the CDC Laboratory Outreach Communication System (LOCS) here.