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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCAR Recall
Reference Number: mdprc 109 04 12 000
Date submitted: 4/24/2012
Manufacturer:Siemens Healthcare Diagnostics
Device Type:IVDs, IMMULITE / IMMULITE
Description:IVDs, Folic acid reagent
Medical Device Identifier:Model: LFK01, Lot/batch no.: Kit lots: 324, 325, 326
Reason of Field Safety Corrective Action:Exhibiting high slopes due to stability issues leading to failed adjustments.
Remedy Action:Customers are instructed to discontinue the use of the IMMULITE/IMMULITE 1000 Folic Acid kit lots 324, 325 and 326 and will be offered new product lot # 327 and above as replacement.
Athorized Representative/Importer/Distributor:Abdulrauf Ibrahim Batterjee & Bros. Company, Jeddah, (02) 6602933
Report Source:NCAR
Source Ref. Number:UK-2012-04-20-074
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments