Magellan Diagnostics has expanded its recall of blood lead testing devices because the devices may show an inaccurately low level of lead.
The earlier recall, which included Magellan’s Lead/Care Plus and Ultra Testing Systems, now includes the LeadCare and LeadCare II Blood Lead Testing Systems. All serial numbers and lot numbers for systems manufactured from September 13 to the present are recalled. More than 7 million Magellan lead testing devices were distributed in the U.S. from January 1, 2014 to May 22, 2017.
The Magellan lead testing systems detect the amount of lead in a blood sample obtained from a finger or heel prick (capillary) or from a vein (venous). Magellan Diagnostics is recalling the LeadCare and the LeadCare II Testing Systems because they may underestimate the blood lead levels (BLL) and give inaccurate results when processing venous blood samples.
Mistakenly low lead level results may lead to improper management and treatment for lead exposure or lead poisoning. Because the use of the recalled Magellan devices may cause serious adverse health consequences, the U.S. Food and Drug Administration (FDA) has categorized this as a Class 1 recall, the FDA’s most serious recall category.
Dangers of Lead Exposure
The Centers for Disease Control and Prevention (CDC) notes that there is no scientifically accepted safe blood lead level for children: even a small amount of lead can cause lasting problems for a child. Lead exposure can lead to irreversible problems including lower IQ, learning difficulties, and behavioral problems.
People can be exposed to lead from a variety of sources—paint, gasoline, solder, and consumer products including some toys and candy. Lead can be present in air, food, water, dust, and soil, and it can be transmitted through breast milk. Some people have occupational exposure. The CDC says lead-based paint is the most widespread and dangerous source of lead exposure for young children.
Lead exposure can cause:
- damage to the brain and nervous system
- slowed growth and development
- learning and behavior problems
- hearing and speech problems
According to the CDC, in at least four million U.S. households children are exposed to high levels of lead. Lead poisoning is particularly dangerous to infants and young children because their bodies may absorb more lead than adults’ bodies do, and their brains and nervous systems are more vulnerable to the damaging effects of lead. Lead poisoning often occurs with no obvious symptoms, and therefore it frequently goes unrecognized until the health problems are severe.
In adults, lead poisoning symptoms include high blood pressure, joint and muscle pain, difficulties with memory or concentration, headache, abdominal pain, mood disorders, educed sperm count and abnormal sperm, miscarriage, stillbirth or premature birth.
The effects of lead poisoning cannot be reversed but treatment can help reduce the blood lead level and stave off further effects.
Parker Waichman notes that many inner-city children have multiple lead exposure risks, because many live in older, less-well-maintained buildings where lead pipes and lead paint may be present.
In many cities, older water systems and lead pipes in older buildings—including schools—expose residents to dangerous levels of lead. The Environmental Protection Agency (EPA) recommends that lead in drinking water should be below 15 parts per billion.
Lead-tainted drinking water has sparked an ongoing crisis in the city of Flint, Michigan. The problems began when the city switched water sources in an effort to save money. When the highly corrosive water from the Flint River was introduced into the city’s system, it corroded the city’s iron water mains, turning the water brown and exposing residents to lead. CNN reports that the water was not being treated with an anti-corrosive agent, as required by federal law.
In late 2015, Flint switched back to Lake Huron water, but lead levels are still unacceptable and scores of residents, in particular children, has experienced health problems from drinking, cooking with, and bathing in the contaminated water.
The FDA recommends that laboratories and health care professionals discontinue using Magellan’s LeadCare System Testing Systems with venous blood samples. (At this time, all LeadCare systems can be used with capillary blood samples.) Laboratories and health care professional should follow the recommendations in the FDA’s May 17 Safety Communication. If a lab has concerns about test results used with Magellan LeadCare devices, alternative testing options are mass spectrometry or atomic absorption methods.
The CDC and the FDA both recommend that parents and at-risk adults speak with a health care provider about possible re-testing if their or their child’s blood was tested with a Magellan lead testing system.
Legal Help for Inaccurate Lead Test Results
If you believe that your or your child(ren) have received inaccurate blood lead level test results from a Magellan LeadCare testing device, the attorneys at Parker Waichman LLP can advise you of your options. To contact the firm, fill out the contact form or call 1-800-YOURLAWYER (1-800-968-7529).