The U.S. Food and Drug Administration has issued a recall of three types of Magellan Diagnostic’s blood lead testing kits, which measure the level of lead in someone’s blood.
The recall is being issued, according to the FDA, because the tests posed “a significant risk of (producing) falsely low blood lead level results.”
Blood lead tests are routinely performed on pregnant women and children — especially in the cities of Milwaukee and Racine — to determine if there are lead contaminants in the home, such as lead pipes that can flake lead into drinking water or lead paint that can chip, turn into dust or be eaten by small children.
Lead exposure has been proven to reduce IQ scores, impulse control and attentiveness in children and was identified as a risk factor for being involved in gun violence later in life.
Emily Tau, spokeswoman for the Milwaukee Health Department, said she was told by Deputy Commissioner of Medical Services Dr. Heather Paradis that the recall had no effect on lead testing performed at the health department and that there had been no tests at Women, Infants and Children clinics due to the coronavirus pandemic.
Tau added: “However, it is potentially a significant issue for primary care practices or other sites that perform point-of-care (POC) testing for young children. To (Dr. Paradis’) knowledge, the Magellan products are the most widely used machines for POC lead testing.”
All pediatric blood lead tests must be reported to the state.
According to the Wisconsin Department of Health Services, approximately 45 clinics and labs in Milwaukee County use LeadCare instruments.
“It’s possible the Wisconsin statistics were affected by this recall although we’re not able to quantify the impact the recall has had at this time,” the department said in a statement issued Thursday to the Milwaukee Journal Sentinel. “We are advising health care providers reach out to all patients and families whose test results may have been invalid due to the use of the recalled test kits.”
The testing kits involved are the LeadCare II, LeadCare Plus and LeadCare Ultra.
You can read more about the recall on the FDA’s website.
Magellan is recommending that patients be retested if they have “suspect results below 5 (micrograms per deciliter)” — the level at which the U.S. Centers for Disease Control and Prevention advise intervention.
According to a news release from the CDC, the recalled tests were distributed between Oct. 27 and June 15. The FDA has advised that no more tests be taken using the recalled devices.
More than 1,000,000 of these tests are in circulation worldwide.
The company first notified distributors in May that there was an issue with its products and the official FDA recall was issued July 1.
The recall comes nearly four years after the FDA accused the company of marketing modified and uncleared versions of its lead testing systems and “failing to submit medical device reports to the FDA after becoming aware of customer complaints involving discrepancies in blood lead test results.”
Officials at Magellan did not respond to questions for this story.
FDA Class I recalls require “a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death,” according to the agency’s website.
The FDA said delayed puberty, reduced postnatal growth, decreased IQ, inattention and childhood behavior problems could result if doctors do not provide proper care based on inaccurate results from the faulty tests.
In 2018, Wisconsin’s Department of Health Services reported that 9.2% of the city’s children age 5 or younger have blood lead levels above 5 mcg/dL. Doctors have expressed concern about the lower levels of testing that occurred during the pandemic while more children were staying indoors, where most lead exposure occurs.
What you should do
Parents and pregnant women who are concerned about whether they or a child was tested using one of the recalled kits should reach out to their primary care physician or pediatrician’s office. They should ask if the kits were used and, if so, whether they or their child should be retested.
Worried about lead poisoning? We want to hear from you. Please fill out this brief survey.