The Food and Drug Administration is accusing a second company of violating federal law in connection with a massive recall of blood-lead test kits for children.
FDA officials issued a warning letter Thursday to Becton Dickinson & Co. of Franklin Lakes, N.Y., which makes the plastic tubes that held blood samples in the faulty tests.
Becton Dickinson (BDX) modified some of its blood tubes without FDA permission, according to an FDA news release. The 120-year-old company 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," Donald St. Pierre, the FDA's deputy director of new product evaluation, said in a news release.
► Jan. 11: Recall of faulty lead poisoning test means kids need to be retested
► Sept. 21: Fewer pregnancies, more fetal deaths in Flint after lead in water
► June 17: Environmental group warns of lead in baby food
The FDA recalled 7 million tests from 2014 to early 2017 after a popular lead testing system, manufactured Magellan Diagnostics of North Billerica, Mass., produced an unknown number of falsely low results. The recall triggered a Centers for Disease Control and Prevention call to retest some of the millions of children who had taken the tests that used blood drawn from veins rather than pin-pricked capillaries.
No level of lead is considered safe in children.
Those whose blood is shown to have 5 micrograms of lead and higher per deciliter of blood are among 2.5% of children ages 1 to 5 who have been tested across the USA with the highest blood lead levels. They're advised to be under a doctor's care to lower those lead levels because even a small amount of lead in the blood affects children's IQ, attention span and academic achievement.
Previous damage cannot be corrected, according to the CDC.
Becton Dickinson is treating the citations and orders in the warning letter "with the highest sense of urgency," Richard Byrd, worldwide president of BD Preanalytical Systems, said 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."
► December 2016: 4 million Americans could be drinking toxic water
► December 2016: Here's what EPA says it's doing about lead in tap water
Becton Dickinson's stock price rose about 0.8% Friday on the New York Stock Exchange and was trading at $227.71 as the market closed.
If the FDA isn't satisfied that its warning letter results in prompt corrections, the agency can take additional actions, including seizure, injunction and civil monetary penalties.
The FDA also determined that Becton Dickinson received a complaint from Magellan Diagnostics, makers of the lead testing systems, which had found a link between certain tubes and inaccurate test results.
"We told (BD) we thought it was the problem, and they said it wasn't their problem," said President and Chief Executive Jack Kenny of Meridian Bioscience, the Newtown, Ohio-based parent of Magellan. His company informed its LeadCare customers to stop using those blood tubes with the diagnostic device.
"We tried to do what was right," Kenny said.
However, the FDA also warned Magellan for violating federal laws regarding how to report complaints and make changes to its medical devices.
Follow Carrie Blackmore Smith on Twitter: @CarrieSmithEnq