Shares of Dutch health tech company Philips took a significant hit, plummeting to the bottom of the European benchmark on Friday, following the U.S. drug regulator’s criticism of the company’s handling of a major product recall.
Amsterdam-listed stock was trading more than 9% lower at 2 p.m. London time, after falling by as much as 10% earlier in the session.
This development marks another setback for Philips concerning the recall of millions of ventilators used to treat sleep apnea, a matter CEO Roy Jakobs had previously emphasized as the company’s “highest priority” this year.
The U.S. Food and Drug Administration (FDA) stated that it does not believe “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 emphasized the need for additional testing and noted that Philips has agreed to fulfill this request.
In response, Philips stated, “Our 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.”
The company further emphasized its alignment with the FDA and other regulators in aiming to ensure the highest standards of patient safety and quality in healthcare delivery.