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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 008 02 17 000
Date submitted: 2/2/2017
Manufacturer:Roche Diagnostics Ltd
Device Type:Elecsys® Anti-HAV
Description:In vitro diagnostic device
Medical Device Identifier:GMMI / Part No: 04854977190
Lot No./Serial No.: All
Reason of Field Safety Corrective Action:When Li-heparin and Na-heparin plasma specimens were compared to serum samples during internal investigations the specified required recovery could not be achieved.
Remedy Action:Actions to be taken by the customer/user:
Please consider the limitations of the new ‘Specimen collection and preparation’ wording in the assay instructions as listed in the attached FSN
Re-testing: In case you suspect discrepant results with Li- and Na-heparin plasma specimens or have specific questions, re-testing might be advisable in concordance with relevant clinical information.
Actions taken by Roche Diagnostics:
A corrected version of the Elecsys® Anti-HAV assay method sheet will be made available soon.
Athorized Representative/Importer/Distributor:FAROUK, MAAMOUN TAMER & COMPANY
Report Source:NCMDR
Source Ref. Number:93A9D8B9DA3A7
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Roche Diagnostics.pdf