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NEW YORK (360Dx) – The US Food and Drug Administration on Tuesday expanded a recall of lead poisoning test to include two additional testing systems from Magellan Diagnostics.

The updated Class I recall now includes Magellan's LeadCare and LeadCare II Blood Lead Testing Systems, all serial and lot numbers. In late May, the agency issued a recall for only the LeadCare Plus and LeadCare Ultra Testing Systems due to possible underestimation of blood lead levels on the systems.

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Oct
09
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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.