From a post I made yesterday on iHub, which was th
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Posted On: 07/02/2017 2:58:07 PM
From a post I made yesterday on iHub, which was then deleted. The post countered one of that message board's favorite topics, that is anything, even lies, are better than DECN.
Post Date: 7/1/2017 1:08:42 PM in reply to 132661100 by ksviking12
Board: Decision Diagnostics Corp. Reason: Off-Topic
KB told me that Unistrip skirted the system so much so that they would have serious issues and not be allowed to sell in the US. And, yes, I have emails on everything I post here to backup what I claim.
Better make sure you know what of you speak. Unistrip in North Carolina was forced to transfer the 510k for its product back to the Taiwanese company who manufactures the strip, in a negotiated settlement with the FDA, effectively buying another two years until OK Biotech is inspected and will have to turn over all of their strip release data. Unistrip can no longer sell its Unistrip1 in the U.S. if its name is on the package. The Taiwanese company OK Biotech upon inspection will have some very difficult questions to answer in their upcoming inspection, and those questions will be asked by FDA Agents from Maryland, not FDA hired help from Taiwan. That will be bad bad bad. Unistrip's issues are sadly similar to Shasta.... you know, flouting the rules, potentially killing people (and they nearly did).
Unistrip has a major design flaw that makes it work randomly often throwing off results that are 40% higher than the patient's actual. In November 2015 EMTs were summoned to a woman's home to find her comotose, lying on the floor. The EMT's suspecting diabetic coma read her glucose to be 30 mg/dl on a Roche meter. A reading that low, which is at the far low end of a glucose meter's ability to read, could have been fatal or if not could have caused brain damage. The EMTs then read the woman's glucose using a Unistrip on a J&J meter and compared the newer reading to the previous reading on the J&J meter with a Unistrip test strip. The comotose woman's glucose read a healthy 70 mg/dl. The previous reading stored in the J&J' meter's memory was 261 mg/dl some 180 minues previous. Obviously the woman received the super abnormally high glucose reading and then panicked and took an emergency shot of insulin, nearly killing herself. I would explain this design flaw but it would not matter (to iHub posters). By the way, all of this was published by the FDA on their public MAUDE system. Unistrip didn't report the event, the EMTs did, and this is not the first time there were death or near death experiences with OK Biotech technology and strips marketed in the U.S. An earlier version proprietary strip called Prodigy certainly led to the death of two people and is suspected in the deaths of 6 others. Both of these strips, Unistrip and Prodigy, were exclusively marketed by two brothers who founded Unistrip.
In February and March 2017 Unistrip was also forced to settle their patent infringement suit and a weak Unistrip countersuit with J&J in an agreement that severely limits them the ability to sell their strip in the U.S., a favorite settlement ploy of J&J. Unistrip is allowed to sell limited quantities of their test strip and what they do sell they cannot grow their market share. J&J first used this settlement ploy with a company who made a First Choice test strip in the mid-1990s. Regardless of the love affair posters scoop, cakes10, ksviking, diarch and alydyr have with Unistrip, their market share was abysmal to begin with. And they were forced to settle even though DECN had defeated J&J's foundational technology patent. Musta been about money or Unistrip's lack thereof.
Some people who used the Unistrip product buy it because it is very, very cheap. Some people do not care about quality. That is why there is the FDA. And in this case the FDA did its job. Unistrip was also kicked off of Amazon in early 2016 due to strip performance issues. They had a 44% 1-star rating.
I would say KB was right. KB told me that Unistrip skirted the system so much so that they would have serious issues and not be allowed to sell in the US. And, yes, I have emails on everything I post here to backup what I claim. Choose another topic and I would think you should be prepared to turn over those emails when they are subpoened.
P.S. I would be happy to provide a discussion about why the Unistrip doesn't really work for those interested.
Post Date: 7/1/2017 1:08:42 PM in reply to 132661100 by ksviking12
Board: Decision Diagnostics Corp. Reason: Off-Topic
KB told me that Unistrip skirted the system so much so that they would have serious issues and not be allowed to sell in the US. And, yes, I have emails on everything I post here to backup what I claim.
Better make sure you know what of you speak. Unistrip in North Carolina was forced to transfer the 510k for its product back to the Taiwanese company who manufactures the strip, in a negotiated settlement with the FDA, effectively buying another two years until OK Biotech is inspected and will have to turn over all of their strip release data. Unistrip can no longer sell its Unistrip1 in the U.S. if its name is on the package. The Taiwanese company OK Biotech upon inspection will have some very difficult questions to answer in their upcoming inspection, and those questions will be asked by FDA Agents from Maryland, not FDA hired help from Taiwan. That will be bad bad bad. Unistrip's issues are sadly similar to Shasta.... you know, flouting the rules, potentially killing people (and they nearly did).
Unistrip has a major design flaw that makes it work randomly often throwing off results that are 40% higher than the patient's actual. In November 2015 EMTs were summoned to a woman's home to find her comotose, lying on the floor. The EMT's suspecting diabetic coma read her glucose to be 30 mg/dl on a Roche meter. A reading that low, which is at the far low end of a glucose meter's ability to read, could have been fatal or if not could have caused brain damage. The EMTs then read the woman's glucose using a Unistrip on a J&J meter and compared the newer reading to the previous reading on the J&J meter with a Unistrip test strip. The comotose woman's glucose read a healthy 70 mg/dl. The previous reading stored in the J&J' meter's memory was 261 mg/dl some 180 minues previous. Obviously the woman received the super abnormally high glucose reading and then panicked and took an emergency shot of insulin, nearly killing herself. I would explain this design flaw but it would not matter (to iHub posters). By the way, all of this was published by the FDA on their public MAUDE system. Unistrip didn't report the event, the EMTs did, and this is not the first time there were death or near death experiences with OK Biotech technology and strips marketed in the U.S. An earlier version proprietary strip called Prodigy certainly led to the death of two people and is suspected in the deaths of 6 others. Both of these strips, Unistrip and Prodigy, were exclusively marketed by two brothers who founded Unistrip.
In February and March 2017 Unistrip was also forced to settle their patent infringement suit and a weak Unistrip countersuit with J&J in an agreement that severely limits them the ability to sell their strip in the U.S., a favorite settlement ploy of J&J. Unistrip is allowed to sell limited quantities of their test strip and what they do sell they cannot grow their market share. J&J first used this settlement ploy with a company who made a First Choice test strip in the mid-1990s. Regardless of the love affair posters scoop, cakes10, ksviking, diarch and alydyr have with Unistrip, their market share was abysmal to begin with. And they were forced to settle even though DECN had defeated J&J's foundational technology patent. Musta been about money or Unistrip's lack thereof.
Some people who used the Unistrip product buy it because it is very, very cheap. Some people do not care about quality. That is why there is the FDA. And in this case the FDA did its job. Unistrip was also kicked off of Amazon in early 2016 due to strip performance issues. They had a 44% 1-star rating.
I would say KB was right. KB told me that Unistrip skirted the system so much so that they would have serious issues and not be allowed to sell in the US. And, yes, I have emails on everything I post here to backup what I claim. Choose another topic and I would think you should be prepared to turn over those emails when they are subpoened.
P.S. I would be happy to provide a discussion about why the Unistrip doesn't really work for those interested.
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