On May 17, 2017, CDC sent a health advisory through its Health Alert Network (CDCHAN-00403). The advisory followed an FDA safety warning about LeadCare blood lead analyzers made by Magellan Diagnostics.
The FDA said that the LeadCare, LeadCare II, LeadCare Ultra and LeadCare Plus analyzers could give falsely low results on venous blood, the blood drawn from a vein. The FDA said the analyzers should no longer be used with venous samples. The warning did not apply to capillary samples from a fingerstick or heelstick. Laboratory tests done by ICP-MS or graphite furnace methods were not expected to give falsely low results. The FDA asked CDC for help on April 24, 2017.
What CDC asked of doctors
- Re-test children who were younger than 6 years (72 months) on May 17, 2017, and who had a venous blood lead result below 10 µg/dL from a LeadCare analyzer.
- Re-test women who were pregnant or breastfeeding at that time and who had a venous test on a LeadCare analyzer.
- No re-test was needed if the doctor was sure a different analyzer tested the venous sample.
- If a re-test result was at or above the CDC reference level or the state or local action level, follow CDC and local guidance.
CDC asked parents to talk with their child’s doctor or the local health department about whether the child needed a new test.
For more on lead and children’s health, see the wellness resources list.
This guidance is from May 2017. It is kept here as a record and is not current advice. Check current guidance from the CDC or your doctor.