Parents advised to re-test children for lead after FDA recall issued

Recall affected testing equipment used locally

Doctors are warning that some children may need to be re-tested for lead exposure after the FDA recalled millions of faulty lead tests from one Massachusetts-based company. 

The recall affects tests conducted between 2014 and 2017 using equipment from Magellan Diagnostics Inc. and according to the FDA, the equipment may show inaccurate levels of lead in the blood, oftentimes lower than the actual level. 

The Centers for Disease Control and Prevention issued the warning in May after learning about the faulty tests. 

The equipment in question was used by Children's Hospital of Wisconsin, but as soon as the recall was issued, doctors stopped using that equipment. 

"It affected lead tests that were venous samples, samples done from a vein in the arm as opposed to a capillary sample which is a sample from a finger poke," said Dr. Heather Paradis, the medical director for community services at Children's. "Now all of the venous samples that are being drawn or sent to them are being analyzed on different equipment." 

She says several hundred families in southeast Wisconsin were affected by the recall. Children's Hospital accessed lab records back in May to notify families. 

Paradis says many families have already taken their children back in for new testing. 

Paradis says long-term exposure to lead in a child's blood can lead to learning disabilities, speech problems and behavioral issues. 

She also says most pediatricians in an office setting use capillary samples for testing, so they wouldn't fall under this recall.

"If a parent does have a concern, I would certainly recommend that they have a conversation with their pediatrician," said Paradis. 

A spokesperson for Sixteenth Street Community Health Centers says they were not affected by the recall as they also use capillary samples.

In October, the FDA sent a warning letter to Magellan Diagnostics Inc. for violations of several federal laws. The agency is still investigating the root cause of the faulty test results. 

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