July 12, 2021
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:
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.
Opt in to receive emails from the CDC Laboratory Outreach Communication System (LOCS).
This Lab Alert was originally published by the CDC Laboratory Outreach Communication System (LOCS) here.
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