贝克曼、梅里埃、日立、新创等产品被召回！其中一家今年已召回5次！

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                    <section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section data-color="rgb(182, 228, 253)" data-custom="rgb(182, 228, 253)"><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><section><p><p><img src="image/20201014/86b79d371e9862b01189f0252a03b2cd_1.jpg" /></p></p></section><section><section><span><strong></strong></span></section><p><span>医疗器械媒体报道先锋</span></p><p><span>分享专业医疗器械知识</span></p></section><section><section><section><span>关注</span></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section></section><p><br  /></p><p><span>来源：体外诊断网&nbsp;作者：天下、木杉&nbsp;</span></p><p><span>数据来源：国家药监局官网&nbsp; &nbsp;</span></p><p><br  /></p><section data-tools="新媒体排版" data-id="13888" data-style-type="正文"><section><section><section><section><section><p><span>2020年至今，国家食品药品监督管理总局已发布96条医疗设备、检验试剂的召回信息，其中涉及IVD行业产品的共16次，涉及贝克曼、奥森多、雅培等多家知名企业。</span></p></section></section></section></section><section><p><br  /></p></section></section></section><p><span>当然，类别都是主动召回。</span></p><p><span><strong><span>&nbsp;</span></strong></span></p><section data-tools="新媒体排版" data-id="13901" data-style-type="标题"><section><section><section><section><p><span><strong>国家药监局最新发布，2家知名械企召回</strong></span></p></section><p><br  /></p></section></section></section></section><section><br  /></section><section><span>9月4日，国家药监局发布召回公告，加拿大艾博科、生物梅里埃2家械企宣布对旗下产品进行召回。</span></section><section><span>&nbsp;</span></section><section data-tools="新媒体排版" data-id="13901" data-style-type="标题"><section><section><section><section><section><span><strong>Epocal Inc.加拿大艾博科有限公司对血气分析检测卡（干式电化学法）主动召回</strong></span></section></section><section><br  /></section></section></section></section></section><section><br  /></section><section><span><span>西门子医学诊断产品（上海）有限公司报告，由于涉及产品特定型号、批次偶发不一致的（低偏倚）血糖结果差异问题，生产商Epocal Inc.加拿大艾博科有限公司对血气分析检测卡（干式电化学法）（注册证号：国械注进20182400183）主动召回。</span><span><strong><span>召回级别为三级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</span></strong></span><br  /></span></section><section><br  /></section><section><p><img src="image/20201014/b76380fd1141a5fb2ceac41a21f1c0b1_2.png" /></p></section><section><br  /></section><section data-tools="新媒体排版" data-id="13901" data-style-type="标题"><section><section><section><section><section><span><strong>生物梅里埃对巧克力琼脂培养基（不加抗生素）主动召回</strong></span></section></section><section><br  /></section></section></section></section></section><section><span>　<br  /></span></section><section><span><span>梅里埃诊断产品（上海）有限公司报告，由于涉及产品特定型号、特定批次在培养葡萄球菌和棒状杆菌时可能产生假阴性结果，生产商生物梅里埃法国股份有限公司 BIOMERIEUX S.A.对巧克力琼脂培养基（不加抗生素）（备案凭证编码：国械备20190903号）主动召回。</span><strong><span>召回级别为三级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。</span></strong></span></section><section><br  /></section><section><span><p><img src="image/20201014/75d898c5623aba14305720adbd9606bb_3.png" /></p>&nbsp;</span></section><section><span><br  /></span></section><section data-tools="新媒体排版" data-id="13901" data-style-type="标题"><section><section><section><section><section><span><strong>2020年国家药监局发布IVD产品召回16次</strong></span></section></section><section><br  /></section></section></section></section></section><section><br  /></section><section><span><span>2020年至今，国家食品药品监督管理总局发布的召回信息中涉及IVD产品的共16次，其中</span><strong><span>贝克曼召回5次，雅培召回3次，奥森多和生物梅里埃各召回2次</span></strong><span>。</span></span></section><section><br  /></section><table cellspacing="0" width="468"><tbody><tr><td width="44" valign="center" nowrap=""><section><span>序号</span></section></td><td width="184" valign="center"><section><span>企业</span></section></td><td width="223" valign="center"><section><span>召回产品</span></section></td><td width="72" valign="center"><section><span>召回级别</span></section></td><td width="72" valign="center"><section><span>召回日期</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>1</span></section></td><td width="184" valign="center"><section><span>Epocal Inc.加拿大艾博科</span></section></td><td width="223" valign="center"><section><span>对血气分析检测卡（干式电化学法）主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0904</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>2</span></section></td><td width="184" valign="center"><section><span>生物梅里埃法国股份有限公司</span></section></td><td width="223" valign="center"><section><span>对巧克力琼脂培养基（不加抗生素）主动召</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0904</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>3</span></section></td><td width="184" valign="center"><section><span>日立诊断</span></section></td><td width="223" valign="center"><section><span>对全自动生化分析仪主动召回</span></section></td><td width="72" valign="center"><section><span>二级</span></section></td><td width="72" valign="center"><section><span>0902</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>4</span></section></td><td width="184" valign="center"><section><span>贝克曼库尔特（美国）</span></section></td><td width="223" valign="center"><section><span>对不饱和铁结合力测定试剂盒（Nitroso-PSAP法）主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0902</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>5</span></section></td><td width="184" valign="center"><section><span>贝克曼库尔特实验系统（苏州）</span></section></td><td width="223" valign="center"><section><span>对乳酸脱氢酶测定试剂盒（乳酸底物法）主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0710</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>6</span></section></td><td width="184" valign="center"><section><span>奥森多临床诊断（美国）</span></section></td><td width="223" valign="center"><section><span>对尿蛋白测定干片（比色法）主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0511</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>7</span></section></td><td width="184" valign="center"><section><span>雅培</span></section></td><td width="223" valign="center"><section><span>对全自动样品处理系统 GLP systems Track主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0507</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>8</span></section></td><td width="184" valign="center"><section><span>英科新创（厦门）</span></section></td><td width="223" valign="center"><section><span>对梅毒螺旋体抗体检测试剂盒（胶体金法）主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0408</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>9</span></section></td><td width="184" valign="center"><section><span>奥森多临床诊断（美国）</span></section></td><td width="223" valign="center"><section><span>对全自动生化分析仪用质控品主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0407</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>10</span></section></td><td width="184" valign="center"><section><span>南京海波医疗器械有限公司</span></section></td><td width="223" valign="center"><section><span>对血液透析浓缩液有限公司主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0326</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>11</span></section></td><td width="184" valign="center"><section><span>贝克曼库尔特实验系统（苏州）</span></section></td><td width="223" valign="center"><section><span>对尿素测定试剂盒（尿素酶-谷氨酸脱氢酶法）主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0320</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>12</span></section></td><td width="184" valign="center"><section><span>生物梅里埃法国股份有限公司</span></section></td><td width="223" valign="center"><section><span>对N端脑钠肽前体测定试剂盒（酶联免疫荧光法）VIDAS NT-proBNP2 (PBN2)主动召回</span></section></td><td width="72" valign="center"><section><span>二级</span></section></td><td width="72" valign="center"><section><span>0228</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>13</span></section></td><td width="184" valign="center"><section><span>贝克曼库尔特（爱尔兰）</span></section></td><td width="223" valign="center"><section><span>对尿液分析试纸条（干化学法）主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0228</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>14</span></section></td><td width="184" valign="center"><section><span>贝克曼库尔特（美国）</span></section></td><td width="223" valign="center"><section><span>对微生物分析仪主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0219</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>15</span></section></td><td width="184" valign="center"><section><span>雅培</span></section></td><td width="223" valign="center"><section><span>对急诊11项测试卡片(干式电化学法)i-STAT CHEM8+ Cartridge主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0219</span></section></td></tr><tr><td valign="center" nowrap=""><section><span>16</span></section></td><td width="184" valign="center"><section><span>雅培</span></section></td><td width="223" valign="center"><section><span>对血气生化多项测试卡片(干式电化学法) Cartridges for the i - STAT Portable Clinical Analyzers主动召回</span></section></td><td width="72" valign="center"><section><span>三级</span></section></td><td width="72" valign="center"><section><span>0219</span></section></td></tr></tbody></table><section><br  /></section><section data-tools="新媒体排版" data-id="13901" data-style-type="标题"><section><section><section><section><section><span><strong>小常识：召回等级有几级？</strong></span></section></section><section><br  /></section></section></section></section></section><section><br  /></section><section><span>&nbsp;在《医疗器械召回管理办法》中规定，医疗器械生产企业确定医疗器械产品存在缺陷的，应立即决定并实施召回，召回分为三级：</span></section><section><span>&nbsp;</span></section><section><span><strong>根据医疗器械缺陷的严重程度，医疗器械召回分为：</strong></span></section><section><br  /></section><section><span>一级召回：使用该医疗器械可能或者已经引起严重健康危害甚至死亡的；</span></section><section><span>二级召回：使用该医疗器械可能或者已经引起暂时的或者可逆的健康危害的；</span></section><section><span>三级召回：使用该医疗器械引起危害的可能性较小但仍需要召回的。</span></section><section><span>&nbsp;</span></section><section><span>医疗器械的危险性从一级到三级逐渐减低，因此医疗器械生产企业做出医疗器械召回决定的，一级召回应在1日内，二级召回应在3日内，三级召回应在7日内，通知到有关医疗器械经营企业、使用单位或者告知使用者。</span></section><section><span><strong><span>&nbsp;</span></strong></span></section><section data-tools="新媒体排版" data-id="13901" data-style-type="标题"><section><section><section><section><section><span><strong>小编说：为什么越是好品牌反而召回数量越多？</strong></span></section></section><section><br  /></section></section></section></section></section><section><br  /></section><section><span>近年来，召回已成为公众熟知的一个名词，而且因牵涉产品质量和安全，不免忧心忡忡。但事实上，企业主动召回，反而体现其对客户和患者安全负责的态度，是一种主动避免问题的行为。相比之下，拒不召回和不敢召回的隐患更大，前者是态度和标准问题，后者则可能存在实质性的安全问题。</span></section><section><span>&nbsp;</span></section><section><span><strong>（1）行业特质使得“召回”难以避免</strong></span></section><section><span><strong><br  /></strong></span></section><section><span>医疗器械医疗器械种类多、跨度大，因设备等级、类型和管理方式等不同而差异巨大。工作人员和患者在使用及滥用医疗器械时存在着很大风险。因此，医疗器械生产安全尤为重要，应当实施从研制、生产到使用、报废全生命周期的监管。</span></section><section><span>&nbsp;</span></section><section><span><strong>（2）主动“召回”是负责任的体现</strong></span></section><section><span><strong><br  /></strong></span></section><section><span>不仅仅是国家对医疗器械的监管力度增加，企业主动发现问题进行召回也越来越普遍，这代表着国内整个医械行业风险管理认知和水平的提升。相对于国人的担心，西方发达国家的民众看待“召回”的态度截然不同。特别是美国的医疗机构，面对“医疗器械召回”通常保持平常心，甚至赞赏企业主动召回具有潜在风险的产品是负责任。不少民众表示，自愿启动对缺陷医疗器械或潜在安全隐患产品的召回，正是医疗器械制造商确保公共用械安全、履行社会责任的良好表现。</span></section><section><span>&nbsp;</span></section><section><span><strong>（3）“召回”大大降低潜在风险成本</strong></span></section><section><span><strong><br  /></strong></span></section><section><span>为何国外的医疗器械生产商更愿意耗费巨资主动召回产品？首先欧美国家早已建立较为完善的医疗事故责任追溯制，若医疗事故是因医疗器械潜在风险引起的，生产企业被勒令支付的赔偿金额，要远远高于事故之前通过自查和主动召回而消除潜在风险的成本。其次还要归因于产品召回险。比如美国不少保险公司设立产品召回险，承保投保人的召回费用和第三方责任，召回成本大部分由保险公司承担，还能消除潜在的危险与赔偿，何乐而不为呢。</span></section><p><br  /></p><section><section 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