Magellan Diagnostics recalled millions of LeadCare testing kits last year due to the risk of falsely low results. Credit:

Hundreds of children in New Orleans may have had falsely low lead test results due to faulty equipment — part of a nationwide problem involving millions of test kits.

The Lens identified one local lab at which the equipment was used: Children’s Hospital of New Orleans.

The faulty equipment particularly affects people tested before May 2017 whose blood samples showed a low or moderately elevated level of lead and didn’t undergo follow-up testing.

Lead is a neurotoxin that causes irreversible brain damage when ingested, particularly in children six years and younger. The U.S. Food and Drug Administration has recommended retesting patients who were tested before mid-May 2017.

Families may not know about the problem. The Louisiana Department of Health and Hospitals can’t track down which children were affected. It says none of the faulty equipment was used in Louisiana, but the agency does not track the type of equipment used in labs. Cathleen Randon, a spokeswoman for LCMC Health, the nonprofit healthcare system that runs Children’s, told The Lens the hospital used it and reported those results to the state.

”In our assessment, the risk of false negatives was very low” due to how samples were handled at the hospital and additional precautions staff took to prevent contamination, Randon said in a statement. But the changes weren’t implemented until November 2016, over two years after the problem began. 

”If there is any reason to believe that their test might’ve been done with faulty equipment, you’re living with the false assumption that they have a low blood lead level.”—Gail Fendley, LeadSafe Louisiana

Later, in April 2017, the hospital switched from using venous samples — drawn from a vein — to capillary samples — drawn from a finger or heel prick. Capillary samples are not affected by the equipment problems.

Based on their blood lead level, children are supposed to receive different types of follow-up services. A falsely low reading could mean children didn’t receive services to which they are entitled, such as additional testing or home inspections to identify sources of lead exposure.

“If there is any reason to believe that their test might’ve been done with faulty equipment, you’re living with the false assumption that they have a low blood lead level,” said Gail Fendley, director of LeadSafe Louisiana. Her group advocates that those tested at Children’s Hospital be retested.

Results may have been inaccurate

Nationwide, as many as 8 million testing kits sold between 2014 and 2017 may have been faulty. But the number of inaccurate tests is probably much lower because some labs used them on capillary samples.

The equipment, manufactured by Magellan Diagnostics, Inc. and Becton Dickinson, was recalled nationwide between April 2017 and earlier this year. It’s unclear how many lead tests in Louisiana and New Orleans used the defective equipment.

Quest Diagnostics and Tamarac Medical, two labs serving the most people in Louisiana, said they never used the equipment that has been recalled.

The U.S. Centers for Disease Control and Prevention has set 5 micrograms per deciliter as a “reference level” for children up to age six. But there is no safe level of lead in children, and levels under 5 can still cause harm.

Statewide, 8,006 children showed lead levels between 5 and 9.9 micrograms per deciliter in their initial tests between 2012 and 2015, according to Louisiana Department of Health and Hospitals data. That’s high enough to raise concern about lead exposure, but not high enough to warrant immediate retesting and other interventions.

In Orleans Parish, 602 test results in 2015 showed lead levels between 5 and 9.9 micrograms per deciliter, according to state data. In 2016, when fewer children in the city were tested, 368 test results were in that range.

Those levels are high enough that parents should have been told to look for the source of lead exposure and to have their children retested within three months, according to current state guidelines. But before guidelines changed in 2016, children testing in this range did not require any follow-up.

At Children’s, those with readings above 10 would have had a confirmation test. Confirmation tests were analyzed by an outside lab using equipment unaffected by the recall.

Test results under 5 may have been inaccurate, too. In 2015, 6,186 tests for children in Orleans Parish had results below 5. In 2016, when fewer children were tested, it was 4,060 tests.

FDA started investigating in 2017

The FDA is looking into two parts of the testing process: testing kits manufactured by Magellan Diagnostics and blood collection tubes made by Becton Dickinson.

In April 2017, Magellan recalled two types of lead testing kits distributed between September 2014 and April 2017 due to reports of underestimated test results. One month later, it expanded the recall to include all four types of rapid lead testing kits. Last March, Becton Dickinson recalled nearly one billion collection tubes.

The equipment leads to faulty results only when it is used together — Becton Dickinson stoppers interfere with Magellan rapid lead testing equipment as it tests blood samples for lead.

The FDA concluded in March that a chemical in the stopper of Becton Dickinson’s collection tubes released a gas into blood samples that caused Magellan’s testing kits to underestimate lead levels. The FDA said it was investigating Magellan for failing to report equipment problems and changing its instructions on how to use the equipment without getting the agency’s approval.

“The agency is still aggressively investigating this issue, including reviewing data from investigations performed by Magellan Diagnostics and BD, requesting additional information from relevant manufacturers regarding the issue, performing inspections as needed, and having additional independent studies performed,” Tara Rabin, an FDA spokeswoman, wrote in an email to The Lens on Friday.

The U.S. Centers for Disease Control and Prevention has recommended retesting for:

  • Any patient who was younger than six years old as of May 17, 2017, and had a venous blood lead test result of less than 10 micrograms per deciliter that was analyzed using any of Magellan’s LeadCare systems
  • Anyone who was pregnant or breastfeeding and had a blood lead test using a LeadCare analyzer before that date

Magellan equipment used at Children’s Hospital lab

Children’s Hospital used the Magellan LeadCare II system to process venous blood samples in its onsite laboratory, said Dr. Randall Craver, the hospital’s laboratory medical director.

LCMC Health also operates other hospitals in the area, but none of them do lead testing, Randon told The Lens.

The onsite laboratory at Children’s processes about 30 blood lead tests per month, meaning about 960 test results between September 2014 and May 2017 may have been faulty. But Children’s has been using Magellan equipment since 2010, performing about 2640 tests between then and May 2017.

Those samples with lead levels elevated above 10 would have been retested at a lab in Utah that does not use Magellan equipment. But the hospital wouldn’t have sought those confirmation tests for children showing lower levels, and those patients may not have received the correct follow-up.

In November 2016, Magellan notified LeadCare II customers that it believed results were distorted when blood came in contact with test tube stoppers.

960Approximate number of blood lead tests performed at Children’s Hospital during Magellan’s recall period2640Approximate number of blood tests performed at Children’s Hospital using Magellan equipment from 2010 to May 2017

Children’s immediately changed how it handled blood samples, Craver said. To lessen the risk of contamination, Craver instructed technicians to run samples immediately after drawing them and to keep collection tubes upright to minimize contact between blood and stoppers.

“We knew that there was an issue, and from the communications, they were thinking prolonged exposure to the cap was leaching out some of the lead,” Craver said.

But the hospital continued to use the LeadCare II analyzer to process venous samples until April 2017. Prior to that, venous blood sampling had been the preferred method at Children’s because it is less painful than sticking a patient’s heel or finger.

“We knew that there was an issue, and from the communications, they were thinking prolonged exposure to the cap was leaching out some of the lead.”—Dr. Randall Craver, Children’s Hospital

Randon said the hospital’s risk of contamination was low even before it made changes to how it handled samples, because lab technicians processed samples soon after they were drawn and did not transport tubes, meaning the samples did not move around as much and were less likely to contact the stoppers.

But according to a lab technician who works with samples at Tulane Lakeside Hospital, blood comes into contact with the rubber stopper as it is drawn. Randon did not respond to The Lens’ questions about the issue.

Craver said he notified physicians affiliated with Children’s to contact patients who tested under 10 micrograms per deciliter about the possibility of inaccurate results.

But he said there was no “coordinated effort” by the hospital to contact patients and families.  Two doctors who spoke with The Lens said they weren’t aware of the problems with the testing equipment; one of them sends his patients to Children’s for lead testing.

Randon told The Lens that the hospital couldn’t determine how many blood tests used with the faulty equipment from 2010 to May 2017 showed low or elevated lead levels. Nor does the company know how many patients came in for retesting in response to the recall.

Were faulty tests used elsewhere around New Orleans?

Most kids in New Orleans with lead levels below 10 were not tested at Children’s Hospital laboratory, based on its estimates of how many lead tests it processes each month and state figures on how many tests are conducted each year.

The Lens contacted more than 30 other clinics and labs in the New Orleans area to see if they used Magellan lead tests.

Two, Vigour Pediatrics in Algiers and Children’s Pediatrics Westbank, use Magellan equipment, but they wouldn’t say if they collect venous samples — the type affected by the faulty equipment — or capillary.

Five — Cypress Pediatrics, Lake Vista Pediatrics, Tri-Parish Pediatrics, Crescent City Pediatrics, and the office of Dr. Lindsay York-Fantaci — use Magellan equipment with capillary samples.

Algiers Pediatrics said it sends bloodwork to Quest Diagnostics for processing. A Quest spokesperson stated that it sends blood samples collected in Louisiana to a testing facility in Houston that has never used Magellan equipment. Nola Community Health Center said it sends samples to Tamarac. A Tamarac spokesperson said it does not use Magellan equipment.

Nine other clinics, Ochsner Baptist Hospital and Tulane-Lakeside Hospital send samples out to third-party laboratories but did not share which labs. Thirteen clinics or labs did not respond.

”The most vulnerable population of the U.S. — children — are the ones who are going to intellectually pay for this mistake.”—Dr. David Dyjack, National Environmental Health Association

Adding to the uncertainty, Randon said Children’s Hospital submits all testing records to the state, including tests done with Magellan equipment before it switched over to capillary samples last year.

But even though Children’s used venous samples collected with the faulty equipment until then, the state Department of Health and Hospitals said it has no records of any venous blood samples processed using Magellan and Becton Dickinson equipment.

“Every lead test should be reported, regardless of the level and regardless of the type of test that was performed,” said Felicia Rabito, associate professor of epidemiology at Tulane School of Public Health and Tropical Medicine. She helped develop the state’s blood lead tracking system.

The CDC says healthcare providers and public health officials, in collaboration with laboratories, are responsible for determining which patients should be retested and contacting those families. Retesting should be done as soon as possible, according to the CDC.

Ethically speaking, the insurance company or the local service provider should cover the cost of retesting, said Dr. David Dyjack, executive director and CEO of the National Environmental Health Association.

“This is tragic from a couple different perspectives,” Dyjack said. “The most vulnerable population of the U.S. — children — are the ones who are going to intellectually pay for this mistake. And it’s incumbent on the healthcare system to do justice by these folks by quickly and efficiently getting children retested so that they can take the appropriate care of themselves so that they can live up to their full human potential.”

This story was updated after publication to include a comment from the FDA.

Kerry Nix

Kerry Nix was a staff writer for The Lens. Her work previously appeared in Pittsburgh