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(yīng)報告和(hé)安全信息網站上發布, 拜(bài)耳保健公司將(jiāng)召回其Ascensia Contour血糖測(cè)試儀(yí)。
監管部門表示,召回原因是加拿大用戶在使用時發現拜耳(ěr)血糖儀的計量單位有誤(wù)。在加拿大(dà)正確的試驗(yàn)單位應(yīng)為mg/dL,而現在拜耳血糖儀卻采用mmol/L為單位。消(xiāo)費者很可能被(bèi)血糖儀顯示的結果誤導,認為自己血糖過高或過低。
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更多>2018-10-12