Chinmax Medical Systems Inc., a cardiac biomarker distributor in China, announced that it disclaims all liability in connection with an official letter it received from the China State Food and Drug Administration (SFDA), in which SFDA confirmed that it has investigated Inverness Medical Beijing (IMB), a subsidiary of Alere Inc., and suspects IMB of submitting 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, 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. 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. 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 SFDA.

Since 1999, Chinmax has held the rights to be exclusive distributor in China of diagnostics products manufactured by Biosite Inc. In 2007, Biosite was acquired by Inverness Medical Innovations Inc. Inverness Medical Beijing, a Chinese subsidiary of Alere, said the company obtained the right to manage contracts between Biosite and Chinmax in December 2008.