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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 001 07 18 000
cobas p 612 pre-analytical system (LCP1)
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.
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.
FAROUK, MAAMOUN TAMER & COMPANY
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.