|By Marketwired .||
|April 30, 2014 09:18 AM EDT||
LOS ANGELES, CA -- (Marketwired) -- 04/30/14 -- Decision Diagnostics Corp. (OTCQB: DECN), and its subsidiary Pharma Tech Solutions, the FDA registered manufacturer and owner/operator for the popular GenStrip, a medical device specifically designed to work with the Johnson & Johnson's LifeScan Ultra family of glucose testing meters, today will comment on the April 29, 2014 FDA issued safety communication about the quality systems issues at Shasta Technologies LLC, the former owner/operator of GenStrip. Shasta is no longer involved with GenStrip.
The company believes that the FDA communication is accurate in its criticism of the repeated failures of Shasta to comply with minimum standards of quality procedure and regulatory compliance. Their continued noncompliance was the motivating factor behind the March 20, 2014 acquisition of the GenStrip Intellectual Property and the 510(k). The existing product supplied by Shasta performed safely and effectively, met or exceeded its own 510(k) described standards, and there have been no reported incidents regarding patient safety or health and it is now under the regulatory control of the company's PharmaTech subsidiary and is fully compliant with the mandated quality procedure policies and documentation.
Keith Berman, Principal Executive Officer of DECN, commented, "We agree with the FDA that Shasta was incapable of properly overseeing GenStrip manufacturing. That is why our subsidiary, PharmaTech Solutions, has acquired GenStrip, its marks, and the 510(k). By virtue of our acquisition, we have assumed all manufacturing and quality systems responsibilities. Shasta's role in GenStrip has ended. We are pleased to announce that the Genstrip product has now been re-branded as, 'PharmaTech GenStrip 50.' GenStrip 50 will be enclosed in redesigned packaging and will shortly be available on our customers' shelves. More importantly, GenStrip 50 will continue to be made in the USA by the same leading diagnostic strip contract manufacturer."
Mr. Berman concluded, "Despite the fact that the issued FDA warning was directed solely to Shasta Technologies and is wholly their responsibility, as the acquirers of the technology and Intellectual Property, Decision Diagnostics and its subsidiary PharmaTech Solutions has committed to replace every box of GenStrip manufactured during Shasta's tenure as manufacturer and owner operator. This guarantee is regardless of where the patient may have purchased the product, or how any Genstrip seller or distributor may have acquired the product, its replacement will be honored. Any replaced product returned to PharmaTech will be destroyed."
Forward Looking Statements:
This release contains forward-looking statements about our business or financial condition that reflect our assumptions and beliefs based on information currently available. We can give no assurance that the expectations indicated by such forward-looking statements will be realized. There may be other risks and circumstances that we are unable to predict. When used in this release, words such as "believes," "expects," "forecasts," "intends," "projects," "plans," "anticipates," "estimates" and similar expressions are intended to identify forward-looking statements, although there may be certain statements not accompanied by such expressions.
GenStrip 50 test strips are a product of PharmaTech Solutions, Inc. and are not manufactured, distributed, endorsed, or approved by nor associated with LifeScan®, Inc. a Johnson & Johnson® Company, manufacturers and distributors of the OneTouch® Ultra® Family of Meters and OneTouch® Ultra® test strips.
Decision Diagnostics Corp.
Sep. 28, 2016 11:21 AM EDT
Sep. 28, 2016 11:00 AM EDT Reads: 1,090
Sep. 28, 2016 11:00 AM EDT Reads: 363
Sep. 28, 2016 10:45 AM EDT Reads: 3,518
Sep. 28, 2016 10:45 AM EDT Reads: 4,101
Sep. 28, 2016 10:45 AM EDT Reads: 220
Sep. 28, 2016 10:30 AM EDT Reads: 4,541
Sep. 28, 2016 10:30 AM EDT Reads: 2,926
Sep. 28, 2016 10:15 AM EDT Reads: 3,247
Sep. 28, 2016 10:00 AM EDT Reads: 1,087
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Sep. 28, 2016 10:00 AM EDT Reads: 4,398
WebRTC is bringing significant change to the communications landscape that will bridge the worlds of web and telephony, making the Internet the new standard for communications. Cloud9 took the road less traveled and used WebRTC to create a downloadable enterprise-grade communications platform that is changing the communication dynamic in the financial sector. In his session at @ThingsExpo, Leo Papadopoulos, CTO of Cloud9, discussed the importance of WebRTC and how it enables companies to focus...
Sep. 28, 2016 10:00 AM EDT Reads: 2,213
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Sep. 28, 2016 09:45 AM EDT Reads: 5,094
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
Sep. 28, 2016 09:15 AM EDT Reads: 3,169
Much of the value of DevOps comes from a (renewed) focus on measurement, sharing, and continuous feedback loops. In increasingly complex DevOps workflows and environments, and especially in larger, regulated, or more crystallized organizations, these core concepts become even more critical. In his session at @DevOpsSummit at 18th Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, showed how, by focusing on 'metrics that matter,' you can provide objective, transparent, and meaningful f...
Sep. 28, 2016 09:00 AM EDT Reads: 2,754