Medical device specifications
Recall Date : 5/4/2019
Recall Class : 2
Common Device  Name: Free Triiodothyronine
Brand Device Name : Abbott
Producer company : Abbott Diagnostics
Manufacturing Country : UNITED STATES
Model : ARCHITECT
Serial No. : تمامی لات نامبرهای مربوط به لیست نامبرهای ذیل:FT3: 7K63 20(4×100 test/kit), 7K63 25(1×100 test/kit), 7K63 27(1×100 test/kit), 7K63 30(4×500 test/kit), 7K63 35(1×500 test/kit), 7K63 32(4×500 test/kit), 7K63 37(1×500 test/kit)
Importer / manufacturer company : Medi Link Ltd
Recall Reason : Carry over کیت ها با مشخصات فوق الذکر با برخی از معرف های دیگر
Describe the quality problem
Date of reporting : 2/4/2019
History of the accident : -
Report type: Product Problem
Reporter Group : National Medical Device Directorate
Survey Results
Corrective action taken :
Recall Status : Open
Description : - اندازه‌گیری به طور مجزا یا در ابتدای Run کاری مطابق با راهکار اعلام شده توسط کمپانی سازنده - یا جمع آوری کیت ها با مشخصات فوق الذکر توسط شرکت نمایندگی و جایگزینی کیت ها در صورت درخواست خریداران
Description

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.



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