X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
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