FDA warns of false coronavirus test results from Thermo Fisher Kit
News comes a month after Connecticut officials reported at least 90 false-positive test results
The Food and Drug Administration on Monday warned health care providers of false-positive coronavirus test results using the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit.
The FDA, which approved Emergency Use Authorization (EUA) for the kit in March, said the issue stems from the kit itself as well as an outdated software system, according to a press release.
Thermo Fisher Scientific has updated its kit instructions, and the FDA is recommending medical professionals "promptly" implement software updates to reduce the frequency of false-positive results.
More
The Food and Drug Administration on Monday warned health care providers of false-positive coronavirus test results using the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit.
The FDA, which approved Emergency Use Authorization (EUA) for the kit in March, said the issue stems from the kit itself as well as an outdated software system, according to a press release.
Thermo Fisher Scientific has updated its kit instructions, and the FDA is recommending medical professionals "promptly" implement software updates to reduce the frequency of false-positive results.
More
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