Lead can damage nearly every system in the human body, and has harmful effects on both adults and children. It is a serious environmental public health threat to children in Ohio.
The Ohio Healthy Homes and Lead Poisoning Prevention Program (OHHLPPP) addresses the needs of lead-poisoned children from birth through 6 years (72 months) of age. The program assists family members, medical care providers and other community members to reduce and prevent lead poisoning. OHHLPPP recognizes that children under the age of 3 years (36 months) are at greatest risk for lead poisoning.
This program is funded by the Centers for Disease Control and Prevention (CDC) for childhood lead poisoning prevention efforts in Ohio. OHHLPPP receives all blood lead laboratory reports on Ohio resident children and contributes to the national database on lead poisoning. The program also promotes the national lead poisoning prevention guidelines set forth by the CDC.
The Ohio Department of Health (ODH) has determined that some Ohio residents have had blood samples for the concentration of lead analyzed using a Magellan Diagnostics LeadCare® analyzer. According to a CDC Health Advisory dated July 6, 2021, “Magellan Diagnostics, Inc. and the U.S. Food and Drug Administration (FDA) have issued a recall notice concerning the use of some LeadCare® Blood Lead Tests (certain LeadCare II, LeadCare Plus, and LeadCare Ultra test kit lots). These lots were distributed between Oct. 27, 2020, and June 15, 2021. The devices might underestimate blood lead levels, which may result in serious injuries. The FDA has identified this as a Class I recall, the most serious type of recall.”
If you are using a LeadCare analyzer in your facilities or are aware of their use in your area, please utilize or pass along this message and following actions.
The Centers for Disease Control and Prevention (CDC) recommends the following actions:
- Discontinue use of all affected test kit lots identified as part of the recall.
- 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 a venous blood sample analyzed with higher complexity testing.
- 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 took place between Oct. 27, 2020, and July 6, 2021, the date of this health advisory.
- Priority for retesting should be given to:
- Children when 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.
- If retesting indicates blood lead levels in excess of the current CDC Blood Level Reference Values (BLRV) or state or local action level, the healthcare provider or public health official should refer to CDC guidelines or state/local guidelines for appropriate follow-up action.
Discuss the recall and retesting recommendations with a parent and/or caregiver of children who meet the retesting criteria.
Ohio Healthy Homes and Lead Poisoning Prevention Program
Bureau of Environmental Health and Radiation Protection
Ohio Department of Health
35 E. Chestnut St.
Columbus, OH 43215
Phone: 1-877-LEADSAFE (532-3723)
Fax: (614) 728-6793
Program Supervisor: Chris Alexander
Environmental Supervisor: Pam Blais
Case Management/Education: Kelly Harris
Principal Investigator: John Belt