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FDA flags accuracy issue with widely used Thermo Fisher (TMO) SARS-CoV-2 test
- Source Link:
- https://apnews.com/520a6d47fd5d847c5046b781e77cd99d
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Additional Information
The warning comes nearly a month after Connecticut public health officials first reported that at least 90 people had received false positive results for the coronavirus. Most of those receiving the false results were residents of nursing homes or assisted living facilities.A spokeswoman for Thermo Fisher said the company was working with FDA “to make sure that laboratory personnel understand the need for strict adherence to the instructions for use.” She added that company data shows most users “follow our workflow properly and obtain accurate results.”The FDA said one possible problem was related to the incorrect use of equipment that rapidly spins samples in preparation for processing. The agency’s letter tells lab workers to follow new instructions developed by the company for this step.A second issue relates to the software used on Thermo Fisher’s testing platform. FDA said labs must upgrade the software to a new version.
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Occurred on:
Aug 18, 2020
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Coronavirus Test