Outset Medical, Inc.
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On June 13, 2022, after the market closed, Outset announced that it had implemented “a shipment hold on the distribution of its Tablo Hemodialysis System for home use pending” a review and clearance of a 510(k) application by the U.S. Food and Drug Administration (“FDA”). The Company withdrew its prior guidance and expected second quarter 2022 revenue of at least $25 million due to the shipment hold.
On this news, Outset’s stock fell $6.95, or 34.1%, to close at $13.46 per share on June 14, 2022, thereby injuring investors.