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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 001 07 18 000
Date submitted: 7/1/2018
Manufacturer:Roche Diagnostics
Device Type:cobas p 612 pre-analytical system (LCP1)
Description:IVD, Specimen processing instrument IVD, automated
Medical Device Identifier:GMMI / Part No: 07563116001

SW Version: All versions from 2.0 and higher
Reason of Field Safety Corrective Action:Roche has confirmed that sample material may potentially come in contact with the pipetting nozzle during operation. The possible presence of biological material on the nozzle has the potential to cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology. However, no complaints of false positives have been received from customers. cobas p 612 (63x) (LCP1) systems that use disposable filter tips are not affected by a potential contamination as the filter tips create a physical barrier preventing liquid exposure to the nozzle.
Remedy Action:If you are using cobas p 612 pre-analytical systems (63x) for aliquoting in combination with non-filter tips, you must use filter tips until the root cause is identified and appropriate Corrective Actions have been implemented.
Roche Diagnostics will send out an update as soon the root cause is identified and corrective measures are available.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY
Report Source:NCMDR
Source Ref. Number:60851EF541239
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Roche Diagnostics.pdf