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A researcher works in a laboratory developing testing for the coronavirus. Photo: Kena Betancur/Getty Images
axios.com - by Jonathan Swan, Caitlin Owens - March 1, 2020
A top federal scientist sounded the alarm about what he feared was contamination in an Atlanta lab where the government made test kits for the coronavirus, according to sources familiar with the situation in Atlanta . . .
. . . The FDA official who visited the Atlanta lab, Timothy Stenzel, is the director of the Office of In Vitro Diagnostics and Radiological Health . . .
. . . Stenzel is a highly-regarded scientist and diagnostics expert. He was on the ground in Atlanta to deal with technical issues and happened to stumble upon the inappropriate procedures and possible contaminants.
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U.S. agency investigating production of faulty coronavirus test
A swab to be used for testing novel coronavirus is seen in the supplies of Harborview Medical Center's home assessment team during preparations to visit the home of a person potentially exposed to novel coronavirus at Harborview Medical Center in Seattle, Washington, U.S. February 29, 2020. REUTERS/David Ryder
reuters.com - by David Shepardson - March 1, 2020
The U.S. Department of Health and Human Services confirmed on Sunday that it is investigating a manufacturing defect in some initial coronavirus test kits that prompted some states to seek emergency approval to use their own test kits . . .
. . . FDA Commissioner Stephen Hahn said in a statement on Sunday that “upon learning about the test issue from CDC (the Centers for Disease Control and Prevention), FDA worked with CDC to determine that problems with certain test components were due to a manufacturing issue.
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Key Missteps at CDC Have Set Back Coronavirus Detection Ability
propublica.com - by Caroline Chen, Marshall Allen, Lexi Churchill and Isaac Arnsdorf - February 28, 2020
The CDC designed a flawed test for COVID-19, then took weeks to figure out a fix so state and local labs could use it.
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