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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 089 02 17 000
Date submitted: 2/23/2017
Manufacturer:Roche Diagnostics Ltd
Device Type:Cobas 8100 automated workflow series
Description:Laboratory system
Medical Device Identifier:- BRF for cobas 8100 GMMI 07439954001
- URF for cobas 8100 GMMI 07441657001
Reason of Field Safety Corrective Action:Buffering May Cause Specimen Spillage
Remedy Action:To solve this issue Roche will release the software version 03-01. There is an immediate mandatory workaround that ensures that this system failure cannot occur. The rack buffering option in all BRF and URF modules is required to be disabled until the software version 03-01 is installed. In case of major spillage on the cobas 8100, affected modules should be set offline. A Roche Service Representative should check and clean the modules before they can return to routine operation (see Operator’s Manual V2.6, “Major spillage”). Affected samples / racks should be carefully inspected. If cross-contamination cannot be excluded, affected samples should be handled according to local regulations incl. the decision whether previously generated results should be reviewed.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY
Report Source:NCMDR
Source Ref. Number:8B754E941F201
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Roche.pdf