Posted July 8, 2021. Past health advisories and alerts are archived for historical purposes and are not maintained or updated.
Centers for Disease Control and Prevention (CDC) Health Alert Network (HAN) has shared this recall notice and recommends appropriate follow-up actions.
Magellan Diagnostics, Inc. and the U.S. Food and Drug Administration (FDA) have issued a recall notice concerning the use of some LeadCare® Blood Lead Tests (certain LeadCare II, LeadCare Plus, and LeadCare Ultra test kit lots). These lots were distributed between October 27, 2020, and June 15, 2021. The use of these devices may cause serious injuries because they might underestimate blood lead levels. The FDA has identified this as a Class I recall, the most serious type of recall. The FDA notified CDC on June 24 that some Magellan Diagnostics blood lead test kits were undergoing a voluntary recall by the manufacturer. The FDA is now recommending that Magellan Diagnostics customers discontinue the use of all affected test kit lots identified as part of the recall and quarantine remaining inventory.
Falsely low results may contribute to health risks in special populations such as young children and pregnant individuals. A pregnant or lactating individual’s exposure to lead is concerning because it may cause health problems for the parent and the developing baby. Obtaining falsely low blood lead level results may lead to inappropriate follow-up assessments, which may result in patient harm, including delayed puberty, reduced postnatal growth, decreased IQ, and inattention and behavior problems in children.
Per CDC guidance, children with blood lead levels at or greater than 5 µg/dL should have had a subsequent test with a venous blood sample for confirmation. LeadCare instruments are currently approved for use only with capillary or finger/heel stick samples. Venous blood confirmation levels are performed with higher complexity testing such as inductively coupled plasma mass spectrometry (ICP- MS) or graphite furnace atomic absorption spectroscopy (GFAAS) and are generally considered more accurate.
More information about blood lead testing can be found by visiting—
More information about the recall can be found by visiting—