Magellan Diagnostics Recalls Blood Lead Tests

U.S. Food and Drug Administration sent this bulletin at 07/01/2021 04:23 PM EDT

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FDA - Center for Devices and Radiological Health

Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results

Magellan Diagnostics is recalling the following LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests, which were distributed from October 27, 2020 to June 15, 2021. The tests were recalled due to a significant risk of falsely low results:

  • LeadCare II Blood Lead Test Kit: Lot codes 2013M, 2014M, 2015M, 2016M, 2017M, 2101M, 2103M, 2105M, 2106M, and 2107M
  • LeadCare Plus Blood Lead Test Kit and LeadCare Ultra Blood Lead Test Kit: Lot codes 2011MU, 2104MU, and 2108MU

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

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Questions?

If you have questions about this recall, contact the Division of Industry and Consumer Education.