By Toby Sterling and Piotr Lipinski
AMSTERDAM (Reuters) -The U.S. Food and Drug Administration (FDA) said it is still not satisfied with how Dutch healthcare technology company Philips has handled a major product recall and the company should conduct additional risk testing.
Its shares fell 9.6% to 16.81 euros at 0726 GMT on Friday.
It was the latest blow to Philips over the recall of millions of sleep apnea and respiratory devices, which has been ongoing since 2021.
“We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” the FDA said in an update published overnight.
In response, Philips said it has agreed with the FDA’s call for more testing and was in discussions with the agency on details.
“Philips’ first priority is the health and well-being of patients, both in terms of providing replacement devices and testing to seek more clarity on the safety of the sleep and respiratory care devices under the recall,” it said.
Philips lost more than two-thirds of its market valuation in 2021-2022, but has staged a modest recovery in 2023.
“This is negative news,” analysts from Bernstein said in a note. “The FDA is clearly still not happy with the way the recall is being handled.”
(Reporting by Toby Sterling and Piotr Lipinski; Editing by Mark Potter and Jan Harvey)
