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The original item was published from 6/7/2022 5:03:00 PM to 6/7/2022 5:07:04 PM.

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Health Department

Posted on: June 7, 2022

[ARCHIVED] Magellan Lead Care II Recall Status

Magellan Lead Test Recall Update

In Jackson County, across the State of Michigan and the nation, there has been a significant decrease in lead testing for young children.  This may be in part due to a recall of testing materials for the Magellan Lead Care machines used by many health care providers and clinics.  As of Feb 14, 2022, according to the Magellan website, distribution of the LeadCare II products began again.  The recall was officially noted as being lifted for LeadCare II products on the FDA site as of March 30, 2022. 

NOTE:  LeadCare Plus and LeadCare Ultra products are still on the recall list at this time.lead care II machine

For more information on the recall and how to order your products for your Lead Care II system, check out the following link:

Magellan website -Information on the LeadCare Test Kit “Controls Out of Range-Low” (“COOR-LO”) Recall 

United States Food and Drug Administration article

U. S. Food and Drug Administration -Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results

Lead Care Testing Statistics Results

Jackson County

State of Michigan

Lowering of the Blood Lead Reference Value

In addition, the Centers for Disease Control lowered the reference level for intervention from 5.0 micrograms per deciliter to 3.5 micrograms per deciliter in October 2021. In May 2022 the State of Michigan Medicaid Policy was updated to align with the CDC action. 

For more information, please call (517) 768-2131.

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