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July Warning Letter Prompts Pause In Dialysis Accessory Distribution

 
• By Brian Bossetta

Following a recent warning letter from the US Food and Drug Administration, Outset Medical has stopped distribution of the TabloCart, an accessory to its Tablo Hemodialysis System.

PAUSE
• Source: Shutterstock

In response to a July warning letter from the US Food and Drug Administration, Outset Medical has decided to pause shipments of its TabloCart with Prefiltration (TabloCart) until the company secures 510(k) clearance for marketing authorization, the company announced in second quarter financial results.

Lacking 510(k) clearance for the TabloCart was one of two concerns cited by the FDA in its July letter to...

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