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Fined 8.755 million | this company supplied refurbished PCR instruments, suspected of refurbishment and counterfeiting

On December 18,Sinopharm Yangzhou Medical Devices Co., LtdBecause of violating the regulations on the supervision and administration of medical devices, Taixing market supervision and Administration Bureau issued a8.755 million yuan ticket

According to the letter of decision on administrative punishment, on January 12, 2021, Taixing market supervision administration received complaints and reported thatSinopharm Yangzhou Medical Devices Co., LtdAndNanjing yushengda Technology Co., Ltd Counterfeiting and supplying fake and inferior products to administrative institutions, The real-time fluorescent quantitative PCR instrument supplied to Taixing Center for Disease Control and prevention was suspected of being refurbished and counterfeited. 泰兴市疾病预防控制中心隶属于泰兴市卫生健康委员会,上述设备是泰兴市卫生健康委员会委托江苏舜天国际集团机械进出口有限公司进行竞争性谈判采购,中标方为Sinopharm Yangzhou Medical Devices Co., Ltd, 采购项目编号 :1802-204112567DWD, The bid winning unit price of real-time fluorescent quantitative PCR instrument is 515000 yuan.

It is reported that the outer packing box of the real-time fluorescent quantitative PCR instrument is marked with model:7500, registration certificate number:gxzz 20163400767, registrant and manufacturer:Life Technology Holdings private Co., Ltd., agent:Yingwei jieji (Shanghai) Free Trade Co., Ltd., serial number:SN 275082376. HoweverAfter verification, life technology holdings private Co., Ltd. has no record of this type of instrument corresponding to the serial number. After identification by China Inspection and Certification Group Beijing company, it is indeed an assembled product. 因此,Sinopharm Yangzhou Medical Devices Co., Ltd的行为违反了《医疗器械监督管理条例》第四十条的规定,依据《医疗器械监督管理条例》第六十三条第一款第一项和《中华人民共和国行政处罚法》第四十九条的规定,泰兴市市场监督管理局决定给予当事人以下行政处罚:

1. Confiscate a set of real-time fluorescent quantitative PCR instrument marked with serial number Sn 275082376;

2、Fine RMB eight million seven hundred and fifty five thousand only (¥ 8755000.00).

As we all knowReal time fluorescent quantitative PCR instrument is an important equipment for nucleic acid detection of COVID-19,而Sinopharm Yangzhou Medical Devices Co., Ltd的违法行为发生时间 During the COVID-19。 Therefore, Taixing market supervision and Administration Bureau decided to giveImpose a heavier punishment and a fine of 17 times。 In the increasingly strengthened regulatory environment, the enterprise should gradually improve the quality management system and strengthen the control of product quality to ensure the safety and effectiveness of products. Whether it is spot check or flight check, it is like an exam. At the moment of opening the book, there are already achievements. Only by doing legal business and doing their own self-examination and self correction, can all machinery enterprises truly prevent trouble before it happens!