Wisconsin DHS Health Alert #33:
Recall of LeadCare® Blood Lead Test Kits
Bureau of Environmental and Occupational Health
July 13, 2021
Key Points:
- The U.S. Food and Drug Administration and Magellan Diagnostics have issued a recall for LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Test Kits distributed between October 27, 2020 and June 15, 2021. These test kits may give falsely low results.
- Providers should immediately discontinue use of all affected lots and quarantine remaining inventory.
- Retest children who were tested with recalled test kits whose results were <5 mcg/dL. Re-testing should be performed using higher complexity testing at a CLIA-certified reference laboratory.
- Retest children who were previously tested using LeadCare test kits if the lot number is unknown and the test was performed between October 27, 2020 and July 6, 2021. Priority should be given to children with symptoms of lead poisoning, those at higher risk of lead exposure, and persons who are pregnant or breastfeeding.
- Further information can be found on the DHS webpage and the CDC Health Advisory.
Dear colleagues,
On July 6, CDC issued a Health Advisory regarding Magellan point-of-care LeadCare II, LeadCare Plus, and LeadCare Ultra test kits. These kits were distributed between October 27, 2020 and June 15, 2021 and may give falsely low results. Providers are highly encouraged to review the CDC Health Advisory and FDA recall information. Providers should retest children tested with affected test kit lots whose results were less than 5 mcg/dL using a venous blood sample and a higher complexity laboratory test (e.g., ICP-MS or GFAAS). Children who were tested using LeadCare with an unknown lot number during October 27, 2020 and July 6, 2021 should also be retested. Further information can be found on the DHS webpage.
Jonathan Meiman, MD
Chief Medical Officer and State Epidemiologist for Environmental and Occupational Health
Wisconsin Department of Health Services
I received your message
|
