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.
美國食品藥品監督管理局7月16日在其不良反應報告和安全信息網站上發布, 拜耳保健公司將召回其Ascensia Contour血糖測試儀。
監管部門表示,召回原因是加拿大用戶在使用時發現拜耳血糖儀的計量單位有誤。在加拿大正確的試驗單位應為mg/dL,而現在拜耳血糖儀卻采用mmol/L為單位。消費者很可能被血糖儀顯示的結果誤導,認為自己血糖過高或過低。