FDA Issues Safety Warning About Magellan LeadCare(R) Analyzers, with CDC Recommendations

Message Details
Date Sent: 05/17/2017 12:38 PM EDT
Sender: Michigan Health Alert Network
Subject: FDA Issues Safety Warning About Magellan LeadCare(R) Analyzers, with CDC Recommendations

Message:
Today the US Food and Drug Administration (FDA) issued a safety warning about use of Magellan Diagnostics LeadCare® analyzers with venous blood samples because they might result in falsely low test results. FDA advises that these analyzers should no longer be used with venous blood samples. The safety alert does not apply to capillary blood lead test results collected by fingerstick or heelstick.
As a result, the Centers for Disease Control and Prevention (CDC) recommends that healthcare providers re-test patients who are:
1) Younger than 6 years (72 months) of age at the time of the alert (May 17, 2017) and had a venous blood lead test result of less than 10 micrograms per deciliter (µg/dL) analyzed using a Magellan Diagnostics’ LeadCare® analyzer at an onsite (e.g., healthcare facility) or at an offsite laboratory.
2) Currently pregnant or lactating women who had a venous blood lead test performed using a Magellan Diagnostics’ LeadCare® analyzer.
For the full CDC Advisory that summarizes the FDA warning and CDC recommendations, see attached.
For additional information at MDHHS contact Martha Stanbury in the MDHHS Childhood Lead Poisoning Prevention Program at stanburym@michigan.gov or 517-284-4820.

​Attachments:

• HAN 403 Potential for Falsely Low Blood Lead Test Results from LeadCare ....pdf