| <P style="TEXT-INDENT: 21pt; LINE-HEIGHT: normal; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">美国食物和药品监管局今天发布召回</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">Elecsys</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">的肌钙蛋白</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">1</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">和其肌钙蛋白</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">1</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">免疫测定剂（来自罗氏诊断公司），原因是与其药剂产生的不符的低水平结果有关。</SPAN></P>
<P style="TEXT-INDENT: 21pt; LINE-HEIGHT: normal; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial"></SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial"><FONT color=#333333><FONT face=Arial>FDA</FONT></FONT></SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">试验室表明</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">“</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">在一些试验室样本中，医生们可能会收到一个不符的低水平结果（上限比肌钙蛋白</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">1</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">实际浓度的最大值一半还低）</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">"</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">这些不正确的结果可能导致严重的不良后果，甚至死亡。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">” <?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p></SPAN></P>
<P style="TEXT-INDENT: 21pt; LINE-HEIGHT: normal; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">这两个试剂的批号分别是</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">163176</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">和</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">163177.</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">在</SPAN><?xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /><st1:chsdate w:st="on" IsROCDate="False" IsLunarDate="False" Day="12" Month="3" Year="2012"><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">2012</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">年</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">3</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">月</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">12</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">日</SPAN></st1:chsdate><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">，罗氏诊断向所有受到损失的消费者致道歉信和要求立即停止肌钙蛋白定免疫试剂销售。试剂为生产于</SPAN><st1:chsdate w:st="on" IsROCDate="False" IsLunarDate="False" Day="29" Month="6" Year="2011"><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">2011</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">年</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">6</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">月</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">29</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">日</SPAN></st1:chsdate><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">到</SPAN><st1:chsdate w:st="on" IsROCDate="False" IsLunarDate="False" Day="13" Month="1" Year="2012"><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">2012</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">年</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">1</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">月</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">13</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">日</SPAN></st1:chsdate><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">的产品。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial"><o:p></o:p></SPAN></P>
<P style="TEXT-INDENT: 21pt; LINE-HEIGHT: normal; mso-char-indent-count: 2.0"><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">肌钙蛋白</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">1</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">是召回中不良后果最为严重的类型。这种试剂很有可能会导致严重的不良后果，乃至死亡。医疗人员能够向药品监督网、</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial">FDA</SPAN><SPAN style="FONT-SIZE: 10.5pt; COLOR: #333333; mso-ascii-font-family: Arial; mso-hansi-font-family: Arial; mso-bidi-font-family: Arial">安全信息局和不良事件局报告此种不良事件。</SPAN><SPAN lang=EN-US style="FONT-SIZE: 10.5pt; COLOR: #333333; FONT-FAMILY: Arial"><o:p></o:p></SPAN></P>
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