FDA warns 2nd company of 'significant violations' in lead test recall

The U.S. Food and Drug Administration is a step closer to identifying what went wrong with blood-lead tests in children from 2014 to 2017.  

The FDA recalled 7 million tests over that timeframe after a popular lead testing system, manufactured by a subsidiary of suburban Cincinnati-based Meridian Bioscience,  produced an unknown number of falsely low results. The recall triggered a CDC call to retest some of the millions of children who had taken the tests.

Now, a second company has been accused of violations of federal law related to the massive recall. The firm makes that the blood tubes that held the blood samples for faulty tests.  

The FDA issued a warning letter to New Jersey-based Becton Dickinson & Co. Thursday, the same day The Enquirer and USA Today published an article about the ongoing ordeal with lead tests.

Becton Dickinson (BD) modified some of its blood tubes without FDA permission, according to an FDA news release. BD,which is headquartered in Franklin Lakes, New Jersey, also failed to provide medical device reports to the federal agency on time. 

"We are continuing to aggressively investigate this issue, including whether the use of BD tubes led to inaccurate lead test results," said Donald St. Pierre, the FDA's deputy director of new product evaluation, in a news release. 

BD is treating the citations and orders in the warning letter "with the highest sense of urgency," said Richard Byrd, worldwide president of BD Preanalytical Systems, in a prepared statement.  

"Ensuring the safety and quality of our products is our top priority at BD," Byrd said in the statement. "We take any potential issue with our products very seriously and are cooperating fully with the FDA on this matter." 

If the FDA isn't satisfied that the warning letter results in prompt corrections, the agency can take additional actions, including seizure, injunction and civil money penalties.

The FDA also determined that BD got a complaint from Magellan Diagnostics, makers of the lead testing systems, which had found a link between certain tubes and inaccurate the tests. 

Jack Kenny is president and CEO of Meridian Bioscience, the Newtown-based parent of Magellan.

"We told (BD) we thought it was the problem and they said it wasn't their problem," said Kenny, who added that his company then informed its LeadCare customers to stop using those blood tubes with the diagnostic device.

"We tried to do what was right," Kenny said.

Magellan, however, also was warned by the FDA for violating federal laws regarding how to report complaints and make changes to its medical devices.

Previous reporting on recall and lead poisoning

Lead tests for millions of kids may be wrong

What is lead and why is it bad?

How to protect your child from lead poisoning

Test maker's parent company faces shareholder lawsuits over recalls