how automated healthcare fails, how you'd know, and what to do at each tier — every claim sourced, reviewed continuously
Magellan's LeadCare devices, used for more than half of US blood lead tests 2013-2017, gave falsely low results on venous samples; the company delayed telling FDA for 21 months.
TierThe automation stayed up and kept producing output that was wrong or went unchecked; there was no outage to fall back from. How tiers are assigned.
Magellan Diagnostics learned during FDA clearance in June 2013 that LeadCare Ultra could give falsely low lead results, released it in late 2013 without informing customers or FDA, and reported to FDA only in April 2015; it disclosed the LeadCare II malfunction in November 2016 and changed user instructions without FDA approval. Tens of thousands of children and adults received inaccurate results. In June 2024 the company pleaded guilty to criminal FD&C Act charges, with a $28.1 million fine, $10.9 million forfeiture and at least $9.3 million for victim compensation.[1]
Tens of thousands of patients, many children, received falsely low lead results (DOJ); individual clinical outcomes not quantified.
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