Medical device specifications
Recall Date : 12/30/2019
Recall Class : 3
Common Device  Name: Brucella Microbiology Reagents
Brand Device Name :
Producer company : انستيتو پاستور ايران
Manufacturing Country : IRAN, ISLAMIC REPUBLIC OF
Model :
Serial No. : سری ساخت: ABT9712 و ABT9804
Importer / manufacturer company : production and research complex of Pasteur Institute of Iran
Recall Reason :
Describe the quality problem
Date of reporting : 12/28/2019
History of the accident : -
Report type: Product Problem
Reporter Group : National Medical Device Directorate
Survey Results
Corrective action taken :
Recall Status : Open
Description :
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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