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:6/8/2017)... Fla. , June 8, 2017  Less than ... that hit more than 200,000 companies, including hospital networks, ... being heralded as one of the largest online extortion ... in the healthcare market, it is imperative that providers ... protect their data from this — and many other ...
(Date:6/7/2017)... June 7, 2017 Endo International plc (NASDAQ: ... 2017, the Hon. Joseph R. Goodwin , U.S. ... West Virginia , entered a case management ... Repair System Products Liability Litigation (the "MDL") that includes ... to provide expert disclosures on specific causation within one ...
(Date:6/5/2017)... 2017 The Cincinnati location ... Inc. (NYSE: DPLO), has been awarded a Top Workplaces ... Results are based on an employee survey administered by ... workplace improvement. The survey measures several aspects of workplace culture, ... ...
Breaking Medicine Technology:
(Date:6/26/2017)... ... 26, 2017 , ... New patients with missing teeth in Fitchburg, ... a referral. Dr. Cotey is a trusted dentist who has placed many dental implants ... Patients with missing teeth in Fitchburg, WI, are encouraged to find out if they ...
(Date:6/25/2017)... ... June 24, 2017 , ... Create a feel-good lyric music video in Final Cut Pro X ... the timeline and write in the lyrics to any song. ProLyric flies in the text ... of the text can be added modularly for optimal control. ProLyric makes editing any music ...
(Date:6/25/2017)... ... 25, 2017 , ... An increase in wetter weather in the Northern California ... with that; a humdinger of an allergy season. A relief from drought conditions is ... misery-causing grass and weed pollen. , “Our patients have been reporting the typical ...
(Date:6/25/2017)... ... ... With a heatwave currently bearing down on Northern California pushing temperatures to the maximum, many ... is easy with laser hair removal. , The process of summer waxing and constantly ... all you want to do is get out, dive in and cool off. There is ...
(Date:6/24/2017)... , ... June 24, 2017 , ... ... offering genetic testing for medications in select Florida and Texas doctors' offices and ... , This new application of genetic testing recognizes the role genes play in ...
Breaking Medicine News(10 mins):