Lawsuit alleges test control and software problems that affected clinical laboratories’ ability to perform COVID-19 testing
A New Jersey-based clinical laboratory has against Thermo Fisher Scientific, alleging problems with their negative controls and interpretation software. Gene Tox Worldwide, doing business as TruGenX, filed the complaint in the US District Court for the District of New Jersey on Feb. 18, 2021.
TruGenX has claimed that, despite Thermo Fisher’s ongoing technical support, the testing failures they experienced with their equipment have remained an unresolved problem. According to TruGenX’s complaint, this led to “significant financial, operational, professional, and reputational hardship due to [Thermo Fisher Scientific’s] products and services.”
In their complaint, TruGenX cites a public alert to providers and clinical laboratories by the US Food and Drug Administration (FDA) that addressed potential issues with sample processing for the Thermo Fisher Scientific TaqPath COVID-19 Combo Kit.
Of note, however, is that this letter was issued in August 2020 and was quickly and thoroughly responded to by Thermo Fisher with software updates and new, in-depth training. TruGenX’s complaint addresses issues that were encountered beginning in September of 2020, after the FDA’s alert had been addressed by Thermo Fisher.
This lawsuit has only recently been filled, and it is important to note that there are still many legal processes that this case must pass through before it becomes evident whether there are any grounds to the allegations being leveled by TruGenX.