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Affymax, Inc. (AFFY) Message Board

  • sonay10 sonay10 Nov 22, 2013 12:14 AM Flag

    Article Part 3

    June 14th, 2012 – New York Times Reports that FDA is Investigating Fresenius Medical Care

    An article released on June 14th raises the public profile of the Fresenius case by reporting that the FDA is investigating the company to determine if Fresenius “violated federal regulations by failing to inform customers of a potentially lethal risk connected to one of its products.” The report gives a brief summary of the case until that date, and includes a statement from Steven Silverman, the director of compliance for the FDA’s medical device division, in which he states, “Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern.”

    June 27thth, 2012 – FDA Issues a Class I Recall of GranuFlo and NaturaLyte Products

    FDA releases a statement announcing a Class I recall of GranuFlo and NaturaLyte, citing that “Inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis.” Class I recalls are the most serious recalls of their kind and the move is considered one of the most important developments in the ongoing case against Fresenius.

    Sentiment: Strong Buy

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