The FDA July 16 issued a MedWatch notice announcing that Bayer Healthcare initiated a Class 1 recall of its Ascensia Contour blood glucose monitoring system.
The product was recalled because the meters reported the wrong units of measure for Canadian users, the agency said. Instead of mmol/L, which is the appropriate measurement for Canadian users, the meters were reporting mg/dL. Consumers may misinterpret the blood glucose results displayed, overestimating blood glucose levels, and may have a reaction of hypoglycemia.
美國(guó)食品藥品監(jiān)督管理局7月16日在其不良反應(yīng)報(bào)告和安全信息網(wǎng)站上發(fā)布, 拜耳保健公司將召回其Ascensia Contour血糖測(cè)試儀。
監(jiān)管部門表示,召回原因是加拿大用戶在使用時(shí)發(fā)現(xiàn)拜耳血糖儀的計(jì)量單位有誤。在加拿大正確的試驗(yàn)單位應(yīng)為mg/dL,而現(xiàn)在拜耳血糖儀卻采用mmol/L為單位。消費(fèi)者很可能被血糖儀顯示的結(jié)果誤導(dǎo),認(rèn)為自己血糖過(guò)高或過(guò)低。
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