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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 035 04 18 000
Date submitted: 4/8/2018
Manufacturer:Roche Diagnostics
Device Type:cobas® 8000 modular analyzer series & cobas e 801 module
Description:In vitro diagnostic devices
Medical Device Identifier:PLUNGER (798-3203)
cobas e 801 module (GMMI 07682913001)
Reason of Field Safety Corrective Action:Roche has received 4 complaints describing an issue with the syringe plunger on a cobas e 801 module PreWash (PW) syringe assembly. Investigations by the manufacturer have shown that this issue may also occur on the cobas e 801 module R1 or R2 reagent syringe assembly.
Remedy Action:Roche Diagnostics’ local representative will contact you to schedule the installation of the modification kit.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY
Report Source:NCMDR
Source Ref. Number:26007B3A6B146
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Roche Diagnostics.pdf