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.
美国食品药品监督管理局7月16日在其不良反应报告和安全信息网站上发布， 拜耳保健公司将召回其Ascensia Contour血糖测试仪。
监管部门表示，召回原因是加拿大用户在使用时发现拜耳血糖仪的计量单位有误。在加拿大正确的试验单位应为mg/dL，而现在拜耳血糖仪却采用mmol/L为单位。消费者很可能被血糖仪显示的结果误导，认为自己血糖过高或过低。