Medical device specifications
Recall Date : 4/28/2019
Recall Class : 2
Common Device  Name: Estradiol
Brand Device Name : Abbott
Producer company : Abbott Diagnostics
Manufacturing Country : UNITED STATES
Serial No. : تمامی لات نامبرهای مربوط به لیست نامبرهای شامل: 7K72-20, 7K72-25, 7K72-35
Importer / manufacturer company : Medi Link Ltd
Recall Reason : تداخل کیت فوق الذکر با داروی میفپریستون (در دو هفته اول مصرف)، که منجر به نتایج کاذب می‌گردد.
Describe the quality problem
Date of reporting : 2/5/2019
History of the accident : -
Report type: Product Problem
Reporter Group : National Medical Device Directorate
Survey Results
Corrective action taken :
Recall Status : Open
Description : اطلاع رسانی به کاربران جهت انجام تست استرادیول بیماران تحت درمان با داروی میفپریستون، دو هفته پس از قطع دارو توسط شرکت نمایندگی

The recall of medical Device is classified into three classes according to the severity of the risks of their safety and performance problems:
Class 1: The most serious type of call. In this class there is a possibility of serious injury and death.
Class 2: Potential damage is temporary and reversible, or the probability of serious injury and death is negligible.
Class 3: The possibility of damage is negligible, while the labeling rules or documents accompanying the General Office or the manufacturer have been violated.

All Rights Reserved Medical Device Directorate of Islamic Republic of Iran.

Powered By NOICT