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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 004 06 11 000
Date submitted: 6/4/2011
Manufacturer:Tcoag
Device Type:Minutex D-Dimer, Reagents
Description:latex agglutination test for semiquantitative determination of fibrin D-dimer
Medical Device Identifier:Minutex D-Dimer kit, Part Number 150707 (Lot Numbers C040002, C042001, C042002, B218005, B341002, B144001 and B155001).
Reason of Field Safety Corrective Action:A failure of the latex reagent, a component of the Minutex D-Dimer kit, Part Number 150707 to cause agglutination may lead to false negative results for patient samples containing levels of greater than 250 ng/ml DDimer.
Remedy Action: Please dispose of the above listed Minutex D-Dimer 150707 Lot Numbers, and indicate the quantity of kits you have disposed of  Notify all End Users of this notification  Complete the attached Fax Back Form
Athorized Representative/Importer/Distributor:Fuad Abdul Jalil Al Fadhli & Sons, Riyadh (01) 4550807
Report Source:NCMDR
Source Ref. Number:CF646ECB0026C
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Tcoag_recall[1].pdf