Philips office constructing in Warsaw, Poland on July 29, 2021. (Photo by Beata Zawrzel/NurPhoto via Getty Images)
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Shares of Dutch health tech company Philips tumbled to the underside of the European benchmark on Friday, after the U.S. drug regulator deemed its handling of a significant product recall inadequate.
The Amsterdam-listed stock finished the day down 7%, paring some losses after falling by as much as 10% earlier within the session.
The announcement reflects one more blow to Philips over the recall of thousands and thousands of ventilators used to treat sleep apnea, which CEO Roy Jakobs earlier this 12 months said could be the the firm’s “highest priority.”
The U.S. Food and Drug Administration (FDA) said overnight that it doesn’t consider that “the testing and evaluation Philips has shared up to now are adequate to totally evaluate the risks posed to users from the recalled devices.”
The FDA said it finds additional testing is needed and noted Philips agreed to perform this request.
In response to the FDA, Philips said in an announcement that its “first priority is the health and well-being of patients, each when it comes to providing alternative devices and testing to hunt more clarity on the protection of the sleep and respiratory care devices under the recall.”
The corporate added that it shares the identical objective because the FDA and other regulators “to make sure the very best standards of patient safety and quality within the delivery of healthcare.”