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