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:9/28/2017)... Cohen Veterans Bioscience and Early Signal Foundation announce a ... sensors for real-time monitoring of patients with trauma-related and ... focused on disruptive health solutions for rare disorders and ... record and integrate behavioral, cognitive, physiological and contextual data. ... ...
(Date:9/23/2017)... 22, 2017 Janssen Biotech, Inc. (Janssen) announced ... from the U.S. Food and Drug Administration (FDA) for ... for the treatment of moderately to severely active rheumatoid ... data are needed to further evaluate the safety of ... RA. "We ...
(Date:9/18/2017)... , Pa. and KALAMAZOO, Mich. , Sept. ... Penn. , and OptiMed Specialty Pharmacy of ... partnership to offer a strategic hub service that expedites ... highly sought-after personal spirometer, Spiro PD 2.0, and wellness ... A spirometer is a medical device used to measure ...
Breaking Medicine Technology:
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( ... today the introduction of an innovative new design of the shoulder pad. The ... get maximum comfort while controlling your pain while using cold therapy. By utilizing ice ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... leader in post-acute health care, have expanded their existing home health joint venture ... , AccentCare has been operating a joint venture home health company with Asante, ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa Mohebi, the ... medical article to the newly revamped Cosmetic Town journal section, featuring ... transplant procedure known as Follicular Unit Extraction (FUE). , Dr. Mohebi ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts ... Washington, D.C., for the 49th Congress of the International Society of Paediatric Oncology ... of the Center for Cancer and Blood Disorders at Children’s National, and ...
(Date:10/12/2017)... GRAND RAPIDS, Mich. (PRWEB) , ... October 12, ... ... OnSite Wellness, has been named one of Michigan’s 2017 Best and Brightest in ... Best and Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 ...
Breaking Medicine News(10 mins):