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Exact Sciences has hiccup with sample mixer, recalls devices

  • The FDA reports that Exact Sciences (EXAS -0.2%) has launched a Class 2 recall of its Sample Mixer v2 Upgrade units that are used with the Cologuard. In an April 28 letter to consignees, the company said it was taking action because of instances of door damage when the Sample Holder opens during a run and the lid makes contact with the Sample Mixer door.
  • A Class 2 recall, an intermediate threat level, is defined as a situation where the device may cause temporary health consequences but the probability of serious problems is remote.
  • CEO Kevin Conroy told Bloomberg that the problem is "closed."

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