FDAnews
www.fdanews.com/articles/199581-becton-dickinson-sues-diagnostics-firm-over-covid-19-test-refunds-after-fda-rejection

Becton Dickinson Sues Diagnostics Firm Over COVID-19 Test Refunds After FDA Rejection

October 16, 2020

Becton Dickinson (BD) has filed suit against clinical diagnostics company BioMedomics for refusing to refund more than $6 million in payments it made for a COVID-19 serology test kit that BD planned to distribute but that the FDA ended up not approving.

According to BD’s complaint in the U.S. District Court for the Eastern District of North Carolina, BioMedomics had agreed to supply multiple units of its COVID-19 IgM/IgG assay to BD, but the FDA told BioMedomics in July it was not approving an Emergency Use Authorization for the test.

BD then notified BioMedomics that it did not intend to continue their relationship and demanded a full refund of its prepayments, but BioMedomics refused, the complaint alleges.

View today's stories