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CDC: Retest blood lead levels of children tested with recalled kits

July 7, 2021

Clinicians should retest blood lead levels in some children who were tested with recalled kits, federal health officials said in an advisory issued Tuesday.

Magellan Diagnostics has recalled its LeadCare II lots 2013M, 2014M, 2015M, 2016M, 2017M, 2101M, 2103M, 2105M, 2106M and 2107M as well as the LeadCare Plus and LeadCare Ultra lots 2011MU, 2104MU and 2108MU, which may be producing falsely low results, according to a notice from the Food and Drug Administration (FDA).

Lead exposure has been associated with health, learning and behavior problems, and no amount is considered safe. The inaccurate test results are especially concerning for children and pregnant women, according to the FDA.

The Centers for Disease Control and Prevention (CDC) is advising that children be retested if

  • they were tested with a recalled LeadCare test kit and their blood lead level was less than 5 micrograms per deciliter (µg/dL) or
  • they were tested with a LeadCare kit with an unknown lot number between Oct. 28, 2020, and July 6, 2021.

Priority should be given to children with symptoms or developmental problems that may be linked to lead exposure, populations at higher risk of elevated blood lead levels and women who are pregnant or breastfeeding. Retesting should be done with a venous blood sample analyzed with higher complexity testing.

Clinicians and laboratories should stop using the recalled tests. Those with questions can contact Magellan at 800- 275-0102 or They should report adverse events to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.

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