Compliance & Safety, Toxicology

Urgent Notice: Lead Testing

On May 17, 2017, the US Food and Drug Administration (FDA) issued a safety communication warning against using venous samples on Point of Care Magellan Diagnostics LeadCare Testing System devices (LeadCare, LeadCare II, LeadCare Plus, and LeadCare Ultra). Venous specimens appear to be at risk for having falsely low results.  Only Capillary (“finger stick” or “heel stick”) specimen types should be used.

IF YOUR OFFICE IS USING ANY OF THE MAGELLAN LEADCARE TESTING SYSTEM DEVICES: please DISCONTINUE the use of VENOUS specimens for testing.

Currently, Lead Testing is performed at the Spectrum Health Regional Laboratory- Toxicology section using Atomic Emission Spectroscopy (AES) for capillary and venous specimens. This testing method is not affected by the FDA warning. The current Spectrum Health standard for Point of Care  Lead capillary screening employs a filter paper collection of a capillary specimen which is submitted to the Spectrum Regional Laboratory for testing. Alternatively,  venous sample collection is acceptable and may be submitted for either screening or confirmation . Please refer to the Spectrum Health Laboratory Catalog for ordering, collection and submission details.

Additional information on the warning and lead testing can be found at these two links:
https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm558733.htm
https://www.cdc.gov/nceh/lead/about/blood_lead_test_safety_alert.html

TEST INFORMATION
Lead Screen, Filter Paper – SH #9677, EPIC #LABLAB2111119
Lead, Blood Level – SH #8261, EPIC #LAB98

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