Chinmax Disclaims Liability Following China SFDA's Confirmation that Inverness Medical Beijing is Suspected of Forging SFDA Verification Seal and Approval Date in Submission o...
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 Be