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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 116 12 17 000
Date submitted: 12/27/2017
Manufacturer:Roche Diagnostics Corp
Device Type:cobas u 601 / cobas u 701
Description:Urine analyzer
Medical Device Identifier:GMMI: 06390498001 & 06390501001
Reason of Field Safety Corrective Action:The analyzer may not transport the rack correctly, so that tubes might be detected twice. As a consequence, the same tube barcode label is read twice and the last tube barcode label is interpreted as the Rack ID. Hence, a sample mismatch is possible between samples processed on the same rack, because the tubes are pipetted in the order given by the rack position and the test result assigned to the wrong sample ID.
Remedy Action:Please perform the described procedure in FSN in order to verify the systems proper function.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY
Report Source:NCMDR
Source Ref. Number:14BDA974081F6
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Roche Diagnostics Corp.pdf