WALTHAM, MA – The Waltham-based lab equipment company that received FDA authorization to ship from them coronavirus test kits to hospitals and laboratories roamed the country in an effort to speedily diagnose the new coronavirus back in March, now has two problems associated with its testing, according to the federal government.
The company, Thermo Fisher Scientific, was tapped in March to produce test kits per week on April 5th. But on Monday, the U.S. Food and Drug Administration warned that the tests might yield false results.
The US Food and Drug Administration (FDA) warns clinical laboratory personnel and healthcare providers of a risk of false results with Thermo Fisher Scientific TaqPath COVID-19 Combo Kit based on two problems related to the test kit and the associated Applied Biosystems COVID -19 Interpretive Software, “the FDA said Monday in an announcement.
The company received complaints from customers, so an investigation began. That was when Thermo Fisher discovered that spinning samples the wrong way could lead to false positive results, the FDA said. The company has since updated its instructions regarding centrifugation to reduce the risk of false positives, according to the FDA.
The second release marked by the FDA was related to the software used by the company. The agency ordered laboratories to upgrade their software to reduce the risk of potentially false negative results such as inconclusive testing, the federal government said.
