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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 023 12 18 000
Date submitted: 12/6/2018
Manufacturer:Roche Diagnostics
Device Type:COBAS INTEGRA® 400 plus and cobas c 111 analyzer
Description:Analyzers, Laboratory, Clinical Chemistry/Immunoassay
Medical Device Identifier:GMMI: 03245233001, 04922859001, 04777433001, 04528778001, 20764337322, 04774248190
Reason of Field Safety Corrective Action:Different types of carry-over were discovered concerning COBAS INTEGRA® 400 plus and cobas c 111 analyzer:
1. Primary carry-over for COBAS INTEGRA® 400 plus
2. Secondary carry-over for COBAS INTEGRA® 400 plus and cobas c 111 analyzer
Remedy Action:1. Primary carry-over for COBAS INTEGRA® 400 plus
Currently there are three different actions depending on the test combination used by the customers:
a) manual set-up of specific EWCs until the TAS 36.01 will be published
b) batch mode for tests where a needle assignment is needed until a TAS 36.01 will be published
c) batch mode for the combination A1MG with OPI or THCII even after TAS 36.01 publication.
Additional information can be found in the attached overview and the Important Information Section.
2. Secondary carry-over for COBAS INTEGRA® 400 plus and cobas c 111 analyzer On COBAS INTEGRA® 400 plus and on cobas c 111 Roche proposes mandatory EWCs after the R1 reagent of the CHOL2 test.
COBAS INTEGRA® 400 plus:
The mentioned EWCs will be part of the upcoming TAS 36.01. Until the TAS is available, customers are requested to install the mandatory EWCs after the R1 of CHOL2 manually.
cobas c 111:
Customers have to install the mandatory EWCs after the R1 of CHOL2 manually.
The updated EWC list for cobas c 111 is part of the updated Instructions for Use (IFU) for the Cleaner (V 7.0) and will be published in Q1/2019.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY
Report Source:NCMDR
Source Ref. Number:2E5C7A455C1A5
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Roche.pdf