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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 042 03 18 001
Date submitted: 12/6/2018
Manufacturer:HUMAN Gesellschaft für Biochemica und Diagnostica GmbH
Device Type:IMTEC-ß2-Glycoprotein I-Antibodies IgG
Description:In vitro diagnostic devices
Medical Device Identifier:Cat. No. ITC59150, Lot 17002 NCMDR Update Code:
Cat. No.: ITC59150
Lot No.: 17004
Reason of Field Safety Corrective Action:During internal evaluations after a customer complaint we noticed for the mentioned lot a problem with stability of reagents. The results of positive sera are not affected and the positive control is in range. Signals of negative sera are found higher than usually and the affected lot may provide false positive results which are not recognized by the negative control.
Remedy Action:Please inform the end user of the above product lots about the problem described here, based on this customer information. Please destroy all kits of the above mentioned lot, which you still may have on stock and those kits, which will be returned from the customers, according to local regulations.
Athorized Representative/Importer/Distributor:Arabian Trade House Est.
Report Source:NCMDR
Source Ref. Number:E7DA37452F26C, C20AA6501C1DE
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: HUMAN Gesellschaft für Biochemica und Diagnostica GmbH.pdf