Medical network - on April 7, in order to strengthen quality supervision and management of medical equipment, to ensure the safety of medical equipment products use effective, administration of the state food and drug supervision and administration organization of calcium (Ca) assay kits, creatine kinase (CK) detection reagent 2 varieties 128 batch of product quality supervision and checking. Now the sampling results announcement is as follows:
A, by sampling project does not meet the prescribed standards of medical equipment products, involving three medical device manufacturing enterprise of two varieties of 3 batch. Specific as follows:
(a) determination of calcium (Ca) kit two companies two batch of products. Anhui fills the biological engineering co., LTD. Production of 1 batch of calcium determination kit (azo arsine Ⅲ method), the accuracy is not in conformity with the prescribed standards; Zhangjiakou Mr Posen technology development co., LTD production of 1 batch of calcium determination kit (azo arsine Ⅲ method), accuracy, linear does not conform to the prescribed standards.
(2) of creatine kinase (CK) detection reagent 1 companies products. Shanghai Asia Pacific biological pharmaceutical co., LTD. Production of 1 Fahrenheit group of creatine kinase (CK) assay kit (continuous monitoring method), linear does not conform to the prescribed standards.
The specific situation of the above sampling does not conform to the stipulations of the standard products, see appendix 1.
Second, sampling project all conform to the standards of medical equipment products involving 73 medical device manufacturing enterprise of two varieties 125 batch, see appendix 2.
Three, found in the above sampling does not conform to the standard products, the state food and drug administration has asked enterprises to local food and drug supervision and administration authority in accordance with the regulations on the supervision and administration of medical devices and the food and drug supervision bureau general office notice on further strengthening medical instrument sample work for drug safety (food do machinery supervisor [2016] 9), to investigate the related enterprises.
Relevant dealing with medical device manufacturing enterprise does not conform to the stipulations of the standard products, does not conform to the stipulations of the standard project risk assessment, according to the severity of the medical equipment defect level of recall, is voluntarily recalling and public recall information. Enterprise local provincial food and drug supervision and administration authority to supervise enterprise recall situation not organize recall shall be ordered to recall; Provided is not in conformity with the standards of medical equipment products cause harm to human body or there is evidence that may endanger human body health, should be taken to suspend the production, import, management, use of emergency control measures. Relevant provincial food and drug supervision and administration department to supervise and urge enterprises to find out the reason as soon as possible, formulate corrective actions and timely rectification in place, the disposal of the situation in 2017 to the public on May 1.
Notice is hereby given that the.
Attachment: 1. The national medical instrument sampling does not conform to the stipulations of the standard product list
序号
|
标示产品名称
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被抽查单位
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标示生产企业
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规格型号
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生产日期/批号/出厂编号
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抽样单位
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检验单位
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不符合标准规定项
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1
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钙测定试剂盒（偶氮砷Ⅲ法）
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安徽大千生物工程有限公司
|
安徽大千生物工程有限公司
|
试剂 R 3×50ml
|
生产日期：20160428；批号：201604044
|
安徽省食品药品监督管理局
|
北京市医疗器械检验所
|
准确性
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2
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钙测定试剂盒（偶氮胂Ⅲ法）
|
张家口奥普森科技发展有限公司
|
张家口奥普森科技发展有限公司
|
40ml×3
|
20160310
|
河北省食品药品监督管理局
|
北京市医疗器械检验所
|
1.准确性；2.线性
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3
|
肌酸激酶（CK）测定试剂盒（连续监测法）
|
上海华氏亚太生物制药有限公司
|
上海华氏亚太生物制药有限公司
|
150ml(R1:60ml×2 R2:30ml×1)
|
16042201
|
上海市食品药品监督管理局
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上海市医疗器械检测所
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线性
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2. The national medical equipment conforms to the standard product list
The food and drug supervision bureau
On April 1, 2017 |
