Decision Diagnostics Corp (DECN)

[LionsTact]

No "Intended use" update since May of LAST YEAR ? ...LOL !!

Theres NO Mention that the strips can be used with the latest models on The Package Insert and the website

In FACT The "Intended Use" says They're for use with meters BEFORE July 10 2010 ....LOL !!

----------------------

(imo) Not Changing the " Intended Use " Since MAY 5th OF LAST YEAR can be costly to sales.

Heres the Intended Use :

" GenStrip™ Test Strips with calibration codes 4, 10 and 13 are for use with OneTouch® Ultra®, Ultra®2 and UltraMini®
Meters purchased before July 2010. They are used to quantitatively measure glucose in fresh capillary whole blood
samples taken from the finger, forearm or palm. Testing is done outside the body (in vitro diagnostic use). They are
indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control. The
system is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates. "

(imo) Not Changing the " Intended Use " Since MAY 5th OF LAST YEAR can be costly to sales.

----------------------

Package insert Link :

http://tinyurl.com/nboa9ur


and website link :

http://tinyurl.com/ledn59h


----------------------

Then I found this review on Amazon

"I have purchased these strips as a substitute for the more costly name brand and saw much lower numbers than I expected. After doing some research was shocked to find that FDA has ordered a recall in April that has not been observed by manufacturer. Do not trust this product it is not safe for you ( dated December 23, 2014 ) "

and Keith Berman replies (on Dec 25, 2014 11:05:47 AM PST) :

" Why would you buy the strips and then do your research ?"

Here's the Amazon Review link

http://tinyurl.com/o8mvkq3

.......WOW !!

----------------------

I also have concerns about Possible LEGAL Complications with a DECN competitor about Bermans "Head to Head to Head" review about a competitors product and NOT identifying himself as a competitor.

In this post from "HealthCentral" the author claims:

"When I asked Berman if he had written the comment attributed to him by name, he told me that “I evaluated them after buying products on Amazon, and I identified myself as an Amazon user.” He did not, however, identify himself as a competitor."

HealthCentral Link the (above) quote was taken from:

http://tinyurl.com/k5x3rwf

and ...

Bermans "Head to Head to Head" Review on Amazon

http://tinyurl.com/mlb3ycw


----------------------

Something else I didn't like reading was ....

"PharmaTech’s Berman claimed that GenStrips meet the existing FDA standard of falling within 20 percent of accuracy most of the time. But he went on to say that his strips fall just short of the 2013 ISO standard and the new draft FDA rules."

http://tinyurl.com/k5x3rwf

.......WOW !!.....Just WOW !!