FDA Issues Alert About Waltham-Based Company Coronavirus Tests

WALTHAM, MA — The Waltham-based lab equipment company that received emergency FDA authorization to start sending its coronavirus test kits to hospitals and labs around the country in an effort to more speedily diagnose the new coronavirus back in March, now has two issues associated with its testing, according to the federal government.

The company, Thermo Fisher Scientific, was tapped in March to produce 5 million test kits per week by April. But Monday, the U.S. Food and Drug Administration warned that the tests may be providing false results.

"The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers of a risk of false results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit based on two issues related to the test kit and the associated Applied Biosystems COVID-19 Interpretive Software," The FDA said Monday in an announcement.

The company received customer complaints so launched an investigation. That's when Thermo Fisher discovered that centrifuging samples the wrong way could lead to false positive results, the FDA said. The company has since updated its instructions related to centrifugation to reduce the risk of false positives, according to the FDA.

The second issue the FDA flagged was connected to the software the company uses. The agency ordered that lab staff upgrade their software to reduce the risk of potentially false negative results or inconclusive tests, the federal government said.

It's not immediately clear how many of the kits were impacted by the problems.

Previously: Waltham Company Tapped To Help Speed Up Coronavirus ...

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