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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 001 11 13 000
Date submitted: 11/3/2013
Manufacturer:Abbott Laboratories Inc
Device Type:AxSYM Valproic Acid, Reagent
Description:IVD, Reagent
Medical Device Identifier:Product Name : List Number : Lot Number AxSYM Valproic Acid Reagent : 07A71-20 : 18439M503
Reason of Field Safety Corrective Action:Abbott has confirmed that some kits of AxSYM Valproic Acid Reagent lot 18439M503 have the potential to generate invalid calibration, control or sample runs due to Net Intensity Too Low, resulting in AxSYM instrument Error Code 1072.
Remedy Action:Contact Abbott Customer Service to order AxSYM Valproic Acid Reagent kits to replace your inventory of lot 18439M503. If a valid calibration and/or control/sample run is obtained, you may continue to use AxSYM Valproic Acid Reagent lot 18439M503 until your replacement lot is received. Immediately, upon receipt of your replacement material, please destroy all remaining inventory of lot 18439M503.
Athorized Representative/Importer/Distributor:Medical supplies & Services Co.Ltd Mediserv, (011) 4780555
Report Source:NCMDR
Source Ref. Number:C1CD1F33D62B6
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Abbott Laboratories.pdf