Medical device specifications
Recall Date : 5/4/2019
Recall Class : 2
Common Device  Name: Activated Partial Thromboplastin Time
Brand Device Name : stago
Producer company : Diagnostica Stago SAS
Manufacturing Country : FRANCE
Model : Staclot¿ LA
Serial No. : 251918,(REF 00600)
Importer / manufacturer company : Fard Avar Azma Iranian Co
Recall Reason : عدم صحت نتایج کیت با مشخصات فوق الذکر در برخی از بازه های زمانی
Describe the quality problem
Date of reporting : 11/14/2018
History of the accident : -
Report type: Product Problem
Reporter Group : National Medical Device Directorate
Survey Results
Corrective action taken :
Recall Status : Terminate
Description : امحاء کیت ها با مشخصات فوق الذکر در محل شرکت نمایندگی
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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