On May 17, 2017, the CDC sent a health advisory through its Health Alert Network. The FDA had warned that Magellan Diagnostics’ LeadCare analyzers could give falsely low blood lead results when used with venous blood samples. Venous blood is blood drawn from a vein. The FDA advised that LeadCare analyzers should no longer be used with venous samples.
Which tests were affected
- The warning covered the LeadCare, LeadCare II, LeadCare Ultra and LeadCare Plus analyzers.
- It covered venous blood lead tests for both children and adults.
- It did not cover capillary tests from a fingerstick or heelstick.
- Lab tests that used the ICP-MS or GFAAS methods were not expected to give falsely low results.
Who the CDC said should be retested
- Children younger than 6 years (72 months) as of May 17, 2017, who had a venous blood lead result below 10 micrograms per deciliter on a LeadCare analyzer.
- Women who were pregnant or breastfeeding and had a venous blood lead test on a LeadCare analyzer.
The CDC asked parents to talk with their child’s health care provider or local health department about a retest. A retest was not needed if the provider was sure that a different analyzer was used. For future tests, the CDC said to send venous samples to labs that used ICP-MS or GFAAS.
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.