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CDC Health Update - Expansion of Recall of LeadCare Blood Lead Tests Due to Risk of Falsely Low Results pdf
Connecticut Medicaid (HUSKY Health)·Family Medicine, Internal Medicine, Pediatrics +1 more·Provider Bulletin
We identified it
Jun 20, 2026
Summary
The CDC has expanded a Class I recall of LeadCare blood lead testing devices distributed from October 2020 to August 2021 due to risk of falsely low results that could cause serious injuries. Healthcare providers must follow CDC recommendations for patient follow-up and alternative testing methods during the shortage.
Action Required
Immediately: Review patient records to identify those tested with recalled LeadCare II, LeadCare Plus, and LeadCare Ultra devices between October 27, 2020 and August 19, 2021. Clinical staff must follow CDC HAN Health Update 454 recommendations for patient retesting and follow-up. Download full guidance from https://emergency.cdc.gov/han/2021/pdf/CDC_HAN_454.pdf to implement appropriate clinical protocols.