Navigation Links
Chinmax Disclaims Liability Following China SFDA's Confirmation that Inverness Medical Beijing is Suspected of Forging SFDA Verification Seal and Approval Date in Submission of Triage BNP Test Registration
Date:6/21/2011

BEIJING, June 21, 2011 /PRNewswire-Asia/ -- Chinmax Medical Systems Inc., a leading cardiac biomarker distributor in China, announced today that it disclaims all liability in connection with an official letter it received from the China State Food and Drug Administration (SFDA) on June 2, 2011, in which the SFDA confirmed that it has investigated Inverness Medical Beijing (IMB), a subsidiary of Alere Inc. (NYSE: ALR), and suspects IMB of submitting of a forged copy of the Triage BNP Test product standard including a fabricated chop of verification and date of verification approval.

The letter was from the SFDA Department of Medical Device Supervision and Administration. According to the letter, after checking with the SFDA archive, the SFDA had verified that the product standard of Triage BNP test (Ref No.10-0439) submitted by IMB was suspected of having a forged SFDA verification seal and approval date. The SFDA further stated that it would take all action required by law upon more investigation.

The Triage BNP test, a cardiac biomarker test for heart failure disease, has been supplied by Alere San Diego, and manufactured by Beckman Coulter Inc., a company of Danaher Corporation. Chinmax is the registered service agent on the Triage BNP test registration in China. However, Chinmax was not aware of and did not participate in IMB's submission of the suspected forged product standard. Accordingly, Chinmax disclaims any and all liability that may result from IMB's conduct in the SFDA.

Since 1999, Chinmax has held the rights to be exclusive distributor in China of diagnostics products manufactured by Biosite Incorporated (now known as "Alere San Diego"), a world leading cardiac biomarkers company in San Diego, California, USA. In 2007, Biosite was acquired by Inverness Medical Innovations, Inc. (now known as Alere Inc. (NYSE: ALR)).  Inverness Medical Beijing, a Chinese subsidiary of Alere Inc., said the company obtained the right to manage contracts between Biosite and Chinmax in December 2008.


'/>"/>
SOURCE Chinmax Medical Systems Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Research Led by Clinical Nurse Specialists Reconfirms Reliability of Temporal Artery Thermometry
2. Masimo Launches New Reusable SpCO® Sensor with Improved Accuracy and Reliability in Low Oxygen Saturation and Elevated Methemoglobin States
3. New FDLIs Food and Drug Policy Forum Focuses on Liability Issues in Vaccine Design Defect Claims
4. Professional Liability Costs for Hospitals and Physicians Continue to Rise, Outpacing Inflation
5. Nonin Medical Announces Its Second-Generation Wrist-Worn Device for European Distribution: Delivering Reliability in the Widest Range of Patient Populations and Clinical Settings
6. Deaconess Health System Selects Omnicells Medication Management System for Product Reliability and Improved Patient Care
7. MedAvante Launches Service to Boost Reliability of Assessments to Reduce Risk of Failed Alzheimers Disease Trials
8. The Oclaro Next-Generation Orion Fiber-Coupled Diode Laser Raises the Bar for Performance, Cost and Reliability for Solid State Lasers
9. U.S. Department of Defense Awards $1.2 Million to Study the Use of Vigabatrin to Reduce the Addictive Liability of Opiates While Still Effectively Managing Pain
10. Alpharma Presents Data Addressing Abuse Liability Features, Safety and Efficacy on ALO-01 (EMBEDA(TM)) (morphine sulfate extended-release with sequestered naltrexone hydrochloride) at the American Pain Society Annual Scientific Session
11. BioDelivery Sciences Confirms 505(b)(2) Pathway for BEMA Buprenorphine/Naloxone for Opioid Dependence Following FDA Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... , Feb. 5, 2016  As people age, it ... multitude of recommended screenings and tests that are linked ... priority. However, for the majority of aging individuals, hearing ... planning. For the 37.5 million American adults who report ... present to make hearing health a 2016 healthy aging ...
(Date:2/5/2016)... , Feb. 5, 2016  Aralez Pharmaceuticals Inc. ... of POZEN Inc. ("POZEN") and Tribute Pharmaceuticals Canada Inc. ("Tribute") ... and shareholders of Tribute. The combined company will operate ... company with operations in Canada , ... United States . Under the terms of the ...
(Date:2/5/2016)... , Feb. 5, 2016 Aethlon Medical, Inc. (Nasdaq: ... Chairman and CEO, will be presenting at Source Capital Group,s ... York, NY at 2:15 p.m. ET on Wednesday, ... Immunotherapy Panel discussion taking place at 3:15 p.m. ET. ... approximately one hour after the conclusion of the live event. ...
Breaking Medicine Technology:
(Date:2/7/2016)... ... February 07, 2016 , ... Dr. ... Kybella® to his medical and surgical expertise. Technically known as deoxycholic acid or ... used as a non-surgical alternative for reduction of fat below the chin (aka ...
(Date:2/6/2016)... , ... February 06, 2016 , ... Shark Finds ... announce the launch of a new DRTV campaign with Belly Bands. , Having a ... everything from sprays to puppy pads and find nothing works, get Belly Bands, ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... ... the availability of the company's lighter, sleeker next generation LYNX VR Indoor Trainer ... , Improvements in design and manufacturing not only reduce the weight of ...
(Date:2/5/2016)... , ... February 05, 2016 , ... ... domestic franchisees of Popeyes Louisiana Kitchen restaurants, launched the 14th annual “Appetite for ... kids and adults with muscular dystrophy, ALS and related diseases that severely limit ...
(Date:2/5/2016)... (PRWEB) , ... February 05, 2016 , ... After years ... General Hospital Burn Unit, plastic and cosmetic surgeon Dr. Wayne Carman transitioned to chief ... Hospital. He successfully completed his first three-year term as chief and began a second ...
Breaking Medicine News(10 mins):