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NEW YORK (360Dx) – Following a warning from the US Food and Drug Administration, Magellan Diagnostics is recalling its lead poisoning test and test systems due to inaccurate test results.

The recall, announced by the FDA today, affects Magellan's LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems. The FDA said that almost 1.1 million LeadCare systems nationwide are being recalled.

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.