Diagnostics from Applied DNA Sciences, Meridian Bioscience and Tide Laboratories are not able to detect omicron, causing false negative results, and should not be used, the agency said.
The medtech giant's stock continued to drop following the Wednesday announcement, while insulin pump rival Tandem Diabetes Care's was boosted by roughly 9.5% when the market closed Thursday.
While the emergence of the omicron variant is muddying next year's medtech outlook, analysts have identified three niches within the sector best positioned to successfully weather the continued strains on the healthcare system.
Puritan Bennet 980 series ventilators can become inoperable during use, according to the FDA recall database. The agency labeled the recall a Class I event, the third such classification for the product since 2015.
The panel questioned whether modifications in the pivotal trial for the device from BrainsGate, a company that attracted early investment from Boston Scientific and J&J, could have compromised the study.
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