The product "Human Papillomavirus Genotyping Detection System " (Registration Certificate No. 20172401912, Exit Number 201706008) produced by Genetel Pharmaceuticals(Shenzhen) Co., Ltd. was sampled by "Shenzhen FDA on August 8, 2017. The result of the sampled inspection was "Power Marker does not meet the requirements".
Genetel Pharmaceuticals(Shenzhen) Co., Ltd. conducted a comprehensive inspection at the first time. The batch of sampling instruments numbered 20170601, a total of 8. In addition to 1 sample, the remaining seven have been sold with factory numbers of 201706001, 201706002, 201706003, 201706004, 201706005, 201706006 and 201706007. It is now planned to arrange technicians of the same batch to go to the customer site for inspection, recall and rectification. 。
Genetel Pharmaceuticals(Shenzhen) Co., Ltd.