沙特阿拉伯王国政府所属的官方政府网站。
周四 25 6月 2026
沙特官方政府网站的域名以下列后缀结尾 gov.sa
沙特阿拉伯王国所有政府机构的官方网站均以 .gov.sa 结尾。
政府网站使用以下协议。 HTTPS 用于加密和安全。
沙特阿拉伯王国所有政府机构的官方网站均以 .gov.sa 结尾。
SFDA Alerts About Error in ‘First Step’ Pregnancy Test Instructions for Use
2019-06-25
SFDA alerted users about a mistake in the Arabic Translation of the Instructions for Use, attached to home ‘First Step Plus’ Pregnancy Test Device with Lot No. C6-130417, thus leading to erroneous interpretation of the test result.
SFDA clarified that the device, manufactured by ‘Aid Diagnostic’, is used for early detection of pregnancy by determining HCG hormone in urine samples, pointing out that a mistake occurred in Lot No. C6-130417, where the Instructions for Use attached to the device indicated that the test result will be Positive (1) for pregnant woman and will be Negative (II) for non-pregnant woman. SFDA noted that the use of the affected product can be continued observing that pregnancy rest result will be Positive (II) for pregnant woman and will be Negative (I) for non-pregnant woman, recommending the importance of referring to a Healthcare facility in case the accuracy of the test result is doubted.
SFDA called on users to report medical devices& products problems by visiting the National Center for Medical Devices Reports Website at: http://ncmdr.sfda.gov.sa
Warning date
2015-09-10
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