Health care providers play an important role in preventing lead exposure by identifying children who are at risk for lead poisoning. Children who are at high risk for lead exposure should be screened at 12 and 24 months, in accordance with Virginia policy. Women who are pregnant should be educated about sources of lead. VDH is committed to supporting health care providers with preventing lead poisoning in children across the Commonwealth.
Magellan Diagnostics Issues Expanded Recall for LeadCare Blood Lead Tests Due to Risk of Falsely Low Results
**Additional information from the CDC is forthcoming. This information will be updated as we learn more.**
Magellan Diagnostics and the United States Food and Drug Administration have issued a recall on LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results. This is a Class 1 recall, the most serious type of recall.
This recall affects both:
- Health care providers and laboratories who may have access to these tests
- People who were tested using these devices
The FDA has significant concerns that the performance of the test may provide falsely low results and may lead to health risks in special populations such as young children and pregnant individuals. A pregnant or lactating individual's exposure to lead is concerning because it not only may cause health problems for the parent but can result in lead exposure to the developing baby. Obtaining falsely low results may lead to patient harm including delayed puberty, reduced postnatal growth, decreased IQ, and inattention and behavior problems in children.
Information on the Recalled Products:
- LeadCare II, LeadCare Plus, and LeadCare Ultra.
- Manufacturing Dates: October 26, 2020 to August 12, 2021
- Distribution Dates: October 27, 2020 to August 19, 2021
- Please visit the FDA recall announcement for links to the lot codes of the recalled products.
CDC & FDA Recommendations
- Continue to schedule and perform required blood lead tests for patients. If LeadCare test kits outside of the recall are unavailable, a higher complexity analysis method should be used.
- Discontinue use of all affected test kit lots identified as part of the recall and quarantine remaining inventory.
- Retest children who were tested with the recalled LeadCare test kits whose results were less than 5 µg/dL, the current CDC-recommended blood lead reference value. Retesting should be done with either a capillary or venous blood sample analyzed with higher complexity testing. Capillary screening results above the BLRV should be confirmed with blood drawn by venipuncture.
- Retest children who were previously tested with a LeadCare test kit if the lot number of the initial test kit is unknown and the test was done after October 27, 2020.
- Prioritize testing for:
- Children where there is clinical concern that symptoms or developmental problems may be related to lead exposure,
- Populations at higher risk of elevated blood lead levels, such as children tested due to Medicaid-required screening or due to other state or local requirements,
- Individuals who are pregnant or breastfeeding, and
- Children who are immigrants, refugees, or recently adopted from outside of the United States.
Providers who may face logistical or capacity-related challenges performing venous blood draws:
- If you are confident the family will comply with an external laboratory visit, then a normal referral should be made.
- If you have concerns about the family’s ability to comply with an external laboratory visit, consider collecting capillary blood samples according to the CDC guidance, then send the specimen to a CLIA compliant laboratory.
- CDC Expansion of Recall of LeadCare Blood Lead Tests Due to Risk of Falsely Low Results
- FDA Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results
CDC Updates Blood Lead Reference Value for Children
The Centers for Disease Control and Prevention (CDC) recently updated its blood lead reference value (BLRV) from 5 µg/dL to 3.5 µg/dL in response to the Lead Exposure Prevention and Advisory Committee (LEPAC) recommendation made on May 14, 2021. The BLRV is intended to identify children with higher levels of lead in their blood compared to most children, based on the 97.5th percentile of the blood lead level (BLL) distribution in U.S. children ages 1–5 years.
For more information on the BLRV change, please visit the CDC press release.
Children in any of the following risk categories should have their blood tested at 12 and 24 months:
- The child is eligible for or receiving benefits from Medicaid or the Special Supplemental Nutrition Program for Women, Infants and Children (WIC);
- The child is living in or regularly visiting a house, apartment, dwelling, structure, or child care facility built before 1960;
- The child is living in or regularly visiting a house, apartment, dwelling, structure, or child care facility built before 1978 that has (i) peeling or chipping paint or (ii) recent (within the last six months) ongoing or planned renovations;
- The child is living in or regularly visiting a house, apartment, dwelling, or other structure in which one or more persons have blood lead testing yielding evidence of lead exposure;
- The child is living with an adult whose job, hobby, or other activity involves exposure to lead;
- The child is living near an active lead smelter, battery recycling plant, or other industry likely to release lead;
- The child's parent, guardian, or other person standing in loco parentis requests the child's blood be tested due to any suspected exposure; or
- The child is a recent refugee or immigrant or is adopted from outside of the United States.
A child in those categories who hasn't previously been tested, or the sibling of a child who has an elevated blood lead level should also be tested.
On October 20, 2016, the Virginia Department of Health modified its disease reporting requirements:
“Lead, reportable levels” means any detectable blood lead level in children 15 years of age and younger and levels greater than or equal to 5 μg/dL in persons older than 15 years of age.
To report a blood lead level, please visit Virginia’s Confidential Morbidity Report Portal.
Please see below for more information on how to address and prevent lead poisoning in other vulnerable and high risk populations.
CEUs for lead:
Guidance for Special Populations
Pregnant and Lactating Women:
Elevated lead levels in pregnancy have been associated with adverse outcomes for both maternal and fetal health. It can cause:
- Increased risk of stillbirth and miscarriage
- Increased risk of the baby being born preterm
- Increased risk of the baby having a low birthweight
- Damage to the baby’s brain, kidneys, and nervous system
- Future developmental and learning problems in the baby
Pregnant women who are at increased risk for lead exposure should be screened for lead.
Pregnant women are at an increased risk of being exposed to lead if they:
- Live in a home built before 1978.
- Are a recent immigrant or refugee.
- Use imported pottery or ceramics to prepare and store food.
- Have old plumbing and pipes in their home.
- Live with someone who has a job or hobby that may expose them to lead, such as welding, metalwork, building renovation, stained glass, casting, or soldering.
- Developed pica during their pregnancy.
- Use traditional folk remedies or cosmetics.
There are some simple steps pregnant women can take that can protect them and their baby from the harmful effects of lead, such as:
- Wet-wipe and wet-mop around window sills and home entrances.
- Washing their hands often.
- Removing their shoes before entering their home.
- If a family member has a job or hobby that exposes them to lead, asking them to take off their shoes before coming inside and change their clothes immediately after coming home.
- Pregnant women should not remodel their home, sand paint, or remove paint with a heat gun.