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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 113 02 17 000
Date submitted: 2/28/2017
Manufacturer:Roche Diagnostics Ltd
Device Type:cobas e 602 module and cobas e 801 module used with cobas® 8000 modular analyzer series
Description:In vitro diagnostic devices
Medical Device Identifier:GMMI / Part No.: 05990378001, 07682913001
Reason of Field Safety Corrective Action:Discrepant information between the previous versions 4.2.1 and 5.0 cobas® 8000 operator’s manuals (OM) for non-standard tubes (NSTs). The version 5.0 OM incorrectly states that 11 to 16 mm diameter NSTs may be used on cobas e 602 and cobas e 801 modules. However, only NST diameters of 13 to 16 mm are permitted on these modules.
Remedy Action:Ensure that only tubes with a diameter of 13 to 16 mm are used on cobas e 602 and cobas e 801 modules.
Replace any available version 5.0 cobas® 8000 operator’s manual by the version 5.1 cobas® 8000 operator’s manual, which states the correct non-standard tube specifications.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY
Report Source:NCMDR
Source Ref. Number:8B7CC606AC27F
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Roche Diagnostics Ltd.pdf